Cefprozil
125 mg/5mL · Powder, for Suspension
- Prescription only
- Active substance
- Cefprozil
- Made by
- Rising Pharma Holdings, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2024-05-18
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or…
ADULTS (13 years and older) UPPER RESPIRATORY TRACT Pharyngitis/Tonsillitis 500 q24h 10 a Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 250 q12h or 500 q12h 10 LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis 500 q12h 10 SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin Structure Infections 250 q12h or 500 q24h or 500 q12h 10 CHILDREN (2 years to 12 years) UPPER RESPIRATORY TRACT b Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10 a SKIN AND SKIN STRUCTURE b Uncomplicated Skin and Skin Structure Infections 20 mg/kg q24h 10 INFANTS & CHILDREN (6 months to 12 years) UPPER RESPIRATORY TRACT b Otitis Media (See INDICATIONS AND USAGE and CLINICAL STUDIES ) 15 mg/kg q12h 10 Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 7.5 mg/kg q12h or 15 mg/kg q12h 10 Renal Impairment Cefprozil may be administered to patients with impaired renal function.
Full directions ↓Cefprozil for oral suspension is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
Cefprozil for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
- When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
- In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
- UPPER RESPIRATORY TRACT Pharyngitis/tonsillitis caused by Streptococcus pyogenes .
- NOTE:
- The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route.
- Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present.
- Otitis Media caused by Streptococcus pneumoniae , Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains).
- (See CLINICAL STUDIES .) NOTE:
- In the treatment of otitis media due to β-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor.
- In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors.
- Acute Sinusitis caused by Streptococcus pneumoniae , Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains).
- LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae , Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains).
- SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes .
- Abscesses usually require surgical drainage.
From the official label · 2024-05-18 · DailyMed
How it works
From this product’s own US prescribing label.
The pharmacokinetic data were derived from the capsule formulation; however, bioequivalence has been demonstrated for the oral solution, capsule, tablet, and suspension formulations under fasting conditions.
Following oral administration of cefprozil to fasting subjects, approximately 95% of the dose was absorbed.
Administration of cefprozil tablet or suspension formulations with food did not affect the extent of absorption (AUC) or the peak plasma concentration (C max ) of cefprozil.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-05-18
Do not take it if
Cefprozil for oral suspension is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Cefprozil for oral suspension is administered orally.
- Population/Infection Dosage (mg) Duration (days) a In the treatment of infections due to Streptococcus pyogenes , cefprozil should be administered for at least 10 days. b Not to exceed recommended adult doses.
- ADULTS (13 years and older) UPPER RESPIRATORY TRACT Pharyngitis/Tonsillitis 500 q24h 10 a Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 250 q12h or 500 q12h 10 LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis 500 q12h 10 SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin Structure Infections 250 q12h or 500 q24h or 500 q12h 10 CHILDREN (2 years to 12 years) UPPER RESPIRATORY TRACT b Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10 a SKIN AND SKIN STRUCTURE b Uncomplicated Skin and Skin Structure Infections 20 mg/kg q24h 10 INFANTS & CHILDREN (6 months to 12 years) UPPER RESPIRATORY TRACT b Otitis Media (See INDICATIONS AND USAGE and CLINICAL STUDIES ) 15 mg/kg q12h 10 Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 7.5 mg/kg q12h or 15 mg/kg q12h 10 Renal Impairment Cefprozil may be administered to patients with impaired renal function.
- The following dosage schedule should be used.
- Creatinine Clearance (mL/min) Dosage (mg) Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. 30 to 120 0 to 29* standard 50% of standard standard standard Hepatic Impairment No dosage adjustment is necessary for patients with impaired hepatic function.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- BEFORE THERAPY WITH CEFPROZIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPROZIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS.
- IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.
- IF AN ALLERGIC REACTION TO CEFPROZIL OCCURS, DISCONTINUE THE DRUG.
- SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
- Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefprozil, and may range in severity from mild diarrhea to fatal colitis.
- Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .
- C. difficile produces toxins A and B which contribute to the development of CDAD.
- Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
- CDAD must be considered in all patients who present with diarrhea following antibiotic use.
- Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
- If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
- Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
- General Prescribing cefprozil in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
- In patients with known or suspected renal impairment (see DOSAGE AND ADMINISTRATION ), careful clinical observation and appropriate laboratory studies should be done prior to and during therapy.
- The total daily dose of cefprozil should be reduced in these patients because high and/or prolonged plasma antibiotic concentrations can occur in such individuals from usual doses.
- Cephalosporins, including cefprozil, should be given with caution to patients receiving concurrent treatment with potent diuretics since these agents are suspected of adversely affecting renal function.
- Prolonged use of cefprozil may result in the overgrowth of nonsusceptible organisms.
- Careful observation of the patient is essential.
- If superinfection occurs during therapy, appropriate measures should be taken.
- Cefprozil should be prescribed with caution in individuals with a history of gastrointestinal disease particularly colitis.
- Positive direct Coombs’ tests have been reported during treatment with cephalosporin antibiotics.
- Information for Patients Phenylketonurics:
- Drug Interactions Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics.
- Drug/laboratory Test Interactions Cephalosporin antibiotics may produce a false positive reaction for glucose in the urine with copper reduction tests (Benedict’s or Fehling’s solution or with Clinitest ® tablets 1 ), but not with enzyme-based tests for glycosuria (e.g., Clinistix ® ).
- A false negative reaction may occur in the ferricyanide test for blood glucose.
- The presence of cefprozil in the blood does not interfere with the assay of plasma or urine creatinine by the alkaline picrate method. 1 Clinitest ® and Clinistix ® are registered trademarks of Bayer Healthcare LLC.
- Carcinogenesis, Mutagenesis, Impairment of Fertility Long term in vivo studies have not been performed to evaluate the carcinogenic potential of cefprozil.
- Cefprozil was not found to be mutagenic in either the Ames Salmonella or E. coli WP2 urvA reversion assays or the Chinese hamster ovary cell HGPRT forward gene mutation assay and it did not induce chromosomal abnormalities in Chinese hamster ovary cells or unscheduled DNA synthesis in rat hepatocytes in vitro .
- Chromosomal aberrations were not observed in bone marrow cells from rats dosed orally with over 30 times the highest recommended human dose based upon mg/m 2 .
- Impairment of fertility was not observed in male or female rats given oral doses of cefprozil up to 18.5 times the highest recommended human dose based upon mg/m 2 .
- Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rabbits, mice, and rats using oral doses of cefprozil of 0.8, 8.5, and 18.5 times the maximum daily human dose (1000 mg) based upon mg/m 2 , and have revealed no harm to the fetus.
- Labor and Delivery Cefprozil has not been studied for use during labor and delivery.
- Treatment should only be given if clearly needed.
- Nursing Mothers Small amounts of cefprozil (<0.3% of dose) have been detected in human milk following administration of a single 1 gram dose to lactating women.
- Pediatric Use (See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .) The safety and effectiveness of cefprozil in the treatment of otitis media have been established in the age groups 6 months to 12 years.
- adults.
- Geriatric Use Of the more than 4500
- General Prescribing cefprozil in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
- In patients with known or suspected renal impairment (see DOSAGE AND ADMINISTRATION ), careful clinical observation and appropriate laboratory studies should be done prior to and during therapy.
- The total daily dose of cefprozil should be reduced in these patients because high and/or prolonged plasma antibiotic concentrations can occur in such individuals from usual doses.
- Cephalosporins, including cefprozil, should be given with caution to patients receiving concurrent treatment with potent diuretics since these agents are suspected of adversely affecting renal function.
- Prolonged use of cefprozil may result in the overgrowth of nonsusceptible organisms.
- Careful observation of the patient is essential.
- If superinfection occurs during therapy, appropriate measures should be taken.
- Cefprozil should be prescribed with caution in individuals with a history of gastrointestinal disease particularly colitis.
- Positive direct Coombs’ tests have been reported during treatment with cephalosporin antibiotics.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rabbits, mice, and rats using oral doses of cefprozil of 0.8, 8.5, and 18.5 times the maximum daily human dose (1000 mg) based upon mg/m 2 , and have revealed no harm to the fetus.
- There are, however, no adequate and well-controlled studies in pregnant women.
- Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
- Small amounts of cefprozil (<0.3% of dose) have been detected in human milk following administration of a single 1 gram dose to lactating women.
- The average levels over 24 hours ranged from 0.25 to 3.3 mcg/mL.
- Caution should be exercised when cefprozil is administered to a nursing woman, since the effect of cefprozil on nursing infants is unknown.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics.
- Concomitant administration of probenecid doubled the AUC for cefprozil.
- The bioavailability of the capsule formulation of cefprozil was not affected when administered 5 minutes following an antacid.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- Single 5000 mg/kg oral doses of cefprozil caused no mortality or signs of toxicity in adult, weanling, or neonatal rats, or adult mice.
- A single oral dose of 3000 mg/kg caused diarrhea and loss of appetite in cynomolgus monkeys, but no mortality.
- Cefprozil is eliminated primarily by the kidneys.
- In case of severe overdosage, especially in patients with compromised renal function, hemodialysis will aid in the removal of cefprozil from the body.
Quoted from the official label, section “Overdosage”.
Use in children
- (See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .) The safety and effectiveness of cefprozil in the treatment of otitis media have been established in the age groups 6 months to 12 years.
- Use of cefprozil for the treatment of otitis media is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients.
- (See CLINICAL STUDIES .) The safety and effectiveness of cefprozil in the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections have been established in the age groups 2 to 12 years.
- Use of cefprozil for the treatment of these infections is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients.
- The safety and effectiveness of cefprozil in the treatment of acute sinusitis have been established in the age groups 6 months to 12 years.
- Use of cefprozil in these age groups is supported by evidence from adequate and well-controlled studies of cefprozil in
- adults.
- Safety and effectiveness in pediatric patients below the age of 6 months have not been established for the treatment of otitis media or acute sinusitis, or below the age of 2 years for the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections.
- However, accumulation of other cephalosporin antibiotics in newborn infants (resulting from prolonged drug half-life in this age group) has been reported.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- Of the more than 4500
- adults treated with cefprozil in clinical studies, 14% were 65 years and older, while 5% were 75 years and older.
- When geriatric patients received the usual recommended adult doses, their clinical efficacy and safety were comparable to clinical efficacy and safety in nongeriatric adult patients.
- Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals to the effects of cefprozil cannot be excluded (see CLINICAL PHARMACOLOGY ).
- Cefprozil is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
- Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
- See DOSAGE AND ADMINISTRATION for dosing recommendations for patients with impaired renal function.
Quoted from the official label, section “Geriatric Use”.
Side effects
- The adverse reactions to cefprozil are similar to those observed with other orally administered cephalosporins.
- Cefprozil was usually well tolerated in controlled clinical trials.
- Approximately 2% of patients discontinued cefprozil therapy due to adverse events.
- The most common adverse effects observed in patients treated with cefprozil are:
- Gastrointestinal:
- Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%).
- Hepatobiliary:
- Elevations of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%), and bilirubin values (<0.1%).
- As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely.
- Hypersensitivity: Rash (0.9%), urticaria (0.1%).
- Such reactions have been reported more frequently in children than in adults.
- Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy.
- CNS:
- Dizziness (1%), hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely (<1%).
- All were reversible.
- Hematopoietic: Decreased leukocyte count (0.2%), eosinophilia (2.3%).
- Renal: Elevated BUN (0.1%), serum creatinine (0.1%).
- Other: Diaper rash and superinfection (1.5%), genital pruritus and vaginitis (1.6%).
- The following adverse events, regardless of established causal relationship to cefprozil, have been rarely reported during postmarketing surveillance:
- anaphylaxis, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum-sickness like reactions, Stevens-Johnson syndrome, and thrombocytopenia.
- Cephalosporin class paragraph In addition to the adverse reactions listed above which have been observed in patients treated with cefprozil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
- Aplastic anemia, hemolytic anemia, hemorrhage, renal dysfunction, toxic epidermal necrolysis, toxic nephropathy, prolonged prothrombin time, positive Coombs’ test, elevated LDH, pancytopenia, neutropenia, agranulocytosis.
- Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced.
- (See DOSAGE AND ADMINISTRATION and OVERDOSAGE .) If seizures associated with drug therapy occur, the drug should be discontinued.
- Anticonvulsant therapy can be given if clinically indicated.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- Phenylketonurics:
- Cefprozil for oral suspension contains 8.4 mg of phenylalanine per 5 mL (1 teaspoonful) constituted suspension for both the 125 mg/5 mL and 250 mg/5 mL dosage forms.
- Patients should be counseled that antibacterial drugs including cefprozil should only be used to treat bacterial infections.
- They do not treat viral infections (e.g., the common cold).
- When cefprozil is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
- Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefprozil or other antibacterial drugs in the future.
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.
- Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.
- If this occurs, patients should contact their physician as soon as possible.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- Cefprozil for Oral Suspension, USP 125 mg/5 mL:
- Each 5 mL of reconstituted suspension contains cefprozil USP equivalent to anhydrous cefprozil 125 mg. 50 mL Bottle NDC 57237-034-50 75 mL Bottle NDC 57237-034-75 100 mL Bottle NDC 57237-034-01 Cefprozil for Oral Suspension, USP 250 mg/5 mL:
- Each 5 mL of reconstituted suspension contains cefprozil USP equivalent to anhydrous cefprozil 250 mg. 50 mL Bottle NDC 57237-035-50 75 mL Bottle NDC 57237-035-75 100 mL Bottle NDC 57237-035-01 All powder formulations for oral suspension contain cefprozil in light pink granular powder with bubble-gum flavored mixture.
- Reconstitution Directions for Oral Suspension Prepare the suspension at the time of dispensing; for ease in preparation, add water in two portions and shake well after each aliquot.
- Total Amount of Water Required for Reconstitution Bottle Size Final Concentration 125 mg/5 mL Final Concentration 250 mg/5 mL 50 mL 35 mL 35 mL 75 mL 52 mL 52 mL 100 mL 70 mL 70 mL After mixing,
- store at 2° to 8°C [36° to 46° F] in a refrigerator and discard unused portion after 14 days.
- Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] prior to constitution.
Quoted from the official label, section “How Supplied”.
What is in it
- Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil is a cis and trans isomeric mixture (≥90% cis). The chemical name for the monohydrate is (6 R ,7 R )-7-[( R )-2-Amino-2-( p -hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is:
- Cefprozil, USP is a white to yellowish powder with a molecular formula for the monohydrate of C 18 H 19 N 3 O 5 S
- H 2 O and a molecular weight of 407.45. Cefprozil for oral suspension, USP is intended for oral administration. Cefprozil for oral suspension, USP contains cefprozil USP equivalent to 125 mg or 250 mg anhydrous cefprozil per 5 mL constituted suspension. In addition, the oral suspension contains the following inactive ingredients:
- aspartame, microcrystalline cellulose, carboxymethylcellulose sodium, citric acid monohydrate, colloidal silicon dioxide, FD&C Red No.3, glycine, polysorbate 80, simethicone emulsion, sodium benzoate, sodium chloride, bubble gum flavor and sucrose. chemical structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Colour dyes
FD&C Red No.3
Some people react to dyes such as tartrazine (Yellow 5) or carmine. - Sugars
sucrose
Relevant to diabetes and dental health. - Aspartame (phenylalanine)
aspartame
People with phenylketonuria (PKU) must avoid phenylalanine.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (4)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 4 of 4
- CefprozilThis onePrescription onlyRising Pharma Holdings, Inc.Colour dyesSugarsAspartame (phenylalanine)
- CefprozilPrescription onlyAurobindo Pharma LimitedColour dyesSugarsAspartame (phenylalanine)
- CefprozilPrescription onlyLupin Pharmaceuticals, Inc.Colour dyesSugarsAspartame (phenylalanine)
- CefprozilPrescription onlyNorthStar Rx LLCColour dyesSugarsAspartame (phenylalanine)
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | Rising Pharma Holdings, Inc. |
|---|---|
| Active substance | Cefprozil |
| Strength | 125 mg/5mL |
| Form | Powder, for Suspension |
| Route | Oral |
| Packs | 100 mL in 1 BOTTLE · 50 mL in 1 BOTTLE |
| NDC | 57237-034 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
22 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet, Film Coated11 products
- Powder, for Suspension9 products
125 mg/5mL4
125 mg/5mL · 4 companies
- Aurobindo Pharma Limited
- Lupin Pharmaceuticals, Inc.
- NorthStar Rx LLC
- Rising Pharma Holdings, Inc. · this page
250 mg/5mL5
- Tablet2 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.