Emend

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Recommended Dosage ( 2.1 ) EMEND capsules in
• adults and pediatric patients 12 years of age and older:
• is 125 mg on Day 1 and 80 mg on Days 2 and 3.
• EMEND for oral suspension in pediatric patients 6 months to less than 12 years of age or pediatric and adult patients unable to swallow capsules:
• see dosing recommendations in Table 3 in the Full Prescribing Information.
• Administer EMEND 1 hour prior to chemotherapy on Days 1, 2, and 3.
• If no chemotherapy is given on Days 2 and 3, administer EMEND in morning.
• See Full Prescribing Information for recommended dosages of concomitant dexamethasone and 5-HT 3 antagonist for HEC and MEC.
• Preparation and Administration ( 2.2 , 2.3 ) EMEND capsules and EMEND for oral suspension can be administered with or without food.
• Swallow EMEND capsules whole.
• EMEND for oral suspension should be prepared by healthcare provider.
• Once prepared, it may be administered either by a healthcare provider, patient, or caregiver.
• For details on preparation see Full Prescribing Information.
• Recommended Dosage
• Adults and Pediatric Patients 12 Years of Age and Older The recommended oral dosage of EMEND capsules, dexamethasone, and a 5-HT 3 antagonist in
• adults and pediatric patients 12 years of age and older who can swallow oral capsules, for the prevention of nausea and vomiting associated with administration of HEC or MEC is shown in Table 1 or Table 2, respectively.
• For patients who cannot swallow oral capsules, EMEND for oral suspension can be used instead of EMEND capsules as shown in Table 3.
• Table 1:
• Recommended Dosing for the Prevention of Nausea and Vomiting Associated with HEC Population Day 1 Day 2 Day 3 Day 4 EMEND capsules Administer EMEND capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3.
• If no chemotherapy is given on Days 2 and 3, administer EMEND capsules in the morning.
• Adults and Pediatric Patients 12 Years and Older 125 mg orally 80 mg orally 80 mg orally none Dexamethasone
• Adults 12 mg orally 8 mg orally 8 mg orally 8 mg orally Pediatric Patients 12 Years and Older If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3) ] .
• Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4.
• A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with EMEND [see Clinical Pharmacology (12.3) ] . 5-HT 3 antagonist
• Adults and Pediatric Patients 12 Years and Older See selected 5-HT 3 antagonist prescribing information for the recommended dosage none none none Table 2:
• Recommended Dosing for the Prevention of Nausea and Vomiting Associated with MEC Population Day 1 Day 2 Day 3 EMEND capsules Administer EMEND capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3.
• If no chemotherapy is given on Days 2 and 3, administer EMEND capsules in the morning.
• Adults and Pediatric Patients 12 Years and Older 125 mg orally 80 mg orally 80 mg orally Dexamethasone
• Adults 12 mg orally none none Pediatric Patients 12 Years and Older If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3) ] .
• Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1.
• A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with EMEND [see Clinical Pharmacology (12.3) ] . 5-HT 3 antagonist
• Adults and Pediatric Patients 12 Years and Older See the selected 5-HT 3 antagonist prescribing information for recommended dosage none none Pediatric Patients 6 Months to less than 12 Years of Age or Pediatric and Adult Patients Unable to Swallow Capsules The recommended dose of EMEND for oral suspension to be administered with a 5-HT 3 antagonist, with or without a corticosteroid, for the prevention of nausea and vomiting associated with administration of HEC or MEC is specified in Table 3.
• Dosing of EMEND for oral suspension is based on weight, to a maximum of 125 mg on Day 1 and 80 mg on Days 2 and 3.
• Dosing in pediatric patients less than 6 kg is not recommended.
• Table 3:
• Recommended Dosing in Pediatric Patients 6 Months to Less than 12 Years of Age or Pediatric and Adult Patients Unable to Swallow Capsules Population Day 1 Day 2 Day 3 Day 4 EMEND for oral suspension After preparation, the final concentration of EMEND for oral suspension is 25 mg/mL [see Dosage and Administration (2.3) ] .
• Administer EMEND for oral suspension 1 hour prior to chemotherapy treatment on Days 1, 2, and 3.
• If no chemotherapy is given on Days 2 and 3, administer EMEND for oral suspension in the morning.
• Pediatric Patients 6 Months to Less than12 Years or Pediatric and Adult Patients Unable to Swallow Capsules 3 mg/kg orally Maximum dose 125 mg 2 mg/kg orally Maximum dose 80 mg 2 mg/kg orally Maximum dose 80 mg none Dexamethasone
• Adults Unable to Swallow Capsules See Table 1 or 2 See Table 1 or 2 See Table 1 or 2 See Table 1 or 2 Pediatric Patients 6 Months to Less than12 Years or Pediatric Patients Unable to Swallow Capsules If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3) ] .
• Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1.
• A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with EMEND [see Clinical Pharmacology (12.3) ] . 5-HT 3 antagonist Pediatric Patients 6 Months to Less than12 Years or Pediatric and Adult Patients Unable to Swallow Capsules See selected 5-HT 3 antagonist prescribing information for the recommended dosage none none none
• 2.2 Preparation Instructions for EMEND for Oral Suspension -- for Healthcare Providers EMEND for oral suspension should be prepared by a healthcare provider.
• Once prepared, it may be administered either by a healthcare provider, patient, or caregiver.
• Before preparing EMEND:
• Do not open the pouch of EMEND until ready to prepare the medicine.
• Store the pouch at room temperature [between 68°F-77°F (20°C-25°C)].
• Table 4:
• Instructions for Healthcare Providers on How to Prepare EMEND for Oral Suspension EMEND for oral suspension is packaged as a kit with one 1 mL oral dosing dispenser, one 5 mL oral dosing dispenser, one cap and one mixing cup. 1.
• Fill the mixing cup with room temperature drinking water. 2.
• Fill the 5 mL oral dosing dispenser with 4.6 mL of water from the mixing cup.
• Make sure no air is in the dispenser - if air is present, remove. 3.
• Discard all the unused water remaining in the mixing cup. 4.
• Add the 4.6 mL of water from the dispenser back into the mixing cup. 5.
• Each pouch of EMEND for oral suspension contains 125 mg of aprepitant which is to be suspended in 4.6 mL of water giving a final concentration of 25 mg/mL.
• Hold the EMEND for oral suspension pouch upright and shake the contents to the bottom before opening the pouch. 6.
• Pour the entire contents of the pouch into the 4.6 mL of water in the mixing cup and snap the lid shut. 7.
• Mix the EMEND suspension gently by swirling 20 times; then gently invert the mixing cup 5 times.
• To prevent foaming, do not shake the mixing cup.
• The mixture will be cloudy pink to light pink. 8.
• Check the EMEND mixture for any clumps or foaming:
• If any clumps are present, repeat Step 7 until there are no clumps.
• If there is any foam, wait for the foam to disappear before going on to Step 9. 9.
• Fill the dispenser with the prescribed dose shown above in Table 3.
• Choose the dispenser based on dose: Use 1 mL dispenser if dose is 1 mL or less.
• Use 5 mL dispenser if dose is more than 1 mL.
• Fill the dispenser with the prescribed dose from the cup.
• If the dose is less than 1 mL round to the nearest 0.1 mL.
• If the dose is more than 1 mL round to the nearest 0.2 mL.
• It is common to have medicine leftover in the cup.
• Make sure no air is in the dispenser - if air is present, remove.
• Make sure the dispenser contains the prescribed dose. 10.
• Place the cap on the dispenser until it clicks. 11.
• If the dose is not administered immediately after measuring, store filled oral dosing dispenser(s) in the refrigerator [between 36°F-46°F (2°C-8°C)] for up to 72 hours prior to use.
• When dispensing dose(s) to the patient or caregiver, instruct them to refrigerate the oral dosing dispenser(s) until they are ready to administer the dose. 12.
• When ready to use, the mixture can be kept at room temperature [between 68°F-77°F (20°C-25°C)] for up to 3 hours. 13.
• Discard the mixing cup along with any remaining suspension.
• Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure
• 2.3 Administration Instructions EMEND capsules and EMEND for oral suspension can be administered with or without food.
• EMEND capsules Swallow capsules whole.
• EMEND for oral suspension The dose will be prepared by the healthcare provider and dispensed to the patient or caregiver in an oral dispenser.
• Keep the dispenser in the refrigerator until administered to the patient.
• The dose can be stored at room temperature for up to 3 hours before use.
• When ready to use, take the cap off the dispenser, place the dispenser in the patient's mouth along the inner cheek on either the right or left side.
• Slowly dispense the medicine.
• The dose must be used within 72 hours of preparation.
• Discard any doses remaining after 72 hours.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

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.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of EMEND for oral suspension have been established in pediatric patients 6 months of age and older and EMEND capsules in pediatric patients 12 years of age and older for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC, including high-dose cisplatin, and MEC.
• Use of EMEND in these age groups is supported by evidence from 302 pediatric patients in a randomized, double-blind, active comparator controlled clinical study (n = 207 patients aged 6 months to less than 12 years, n = 95 patients aged 12 through 17 years).
• EMEND was studied in combination with ondansetron with or without dexamethasone (at the discretion of the physician) [see Clinical Studies (14.3) ] .
• Adverse reactions were similar to those reported in adult patients [see Adverse Reactions (6.1) ] .
• The safety and effectiveness of EMEND for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months.
• Juvenile Animal Study A study was conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development.
• Rats were treated at oral doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended pediatric human dose and exposure in female rats equivalent to the pediatric human exposure) from the early postnatal period (Postnatal Day 10) through Postnatal Day 58.
• Slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs.
• There were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the 544 adult cancer patients treated with EMEND in CINV clinical studies, 31% were aged 65 and over, while 5% were aged 75 and over.
• Other reported clinical experience with EMEND has not identified differences in responses between elderly and younger patients.
• In general, use caution when dosing elderly patients as they have a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .

Quoted from the official label, section “Geriatric Use”.

Side effects

• Most common adverse reactions (≥3%) are ( 6.1 ):
• Adults:
• fatigue, diarrhea, asthenia, dyspepsia, abdominal pain, hiccups, white blood cell count decreased, dehydration, and alanine aminotransferase increased.
• Pediatrics:
• neutropenia, headache, diarrhea, decreased appetite, cough, fatigue, hemoglobin decreased, dizziness, and hiccups.
• To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
• The overall safety of EMEND was evaluated in approximately 6800 individuals.
• Adults In 2 active-controlled, double-blind clinical trials in patients receiving highly emetogenic chemotherapy (HEC) (Studies 1 and 2), EMEND in combination with ondansetron and dexamethasone (EMEND regimen) was compared to ondansetron and dexamethasone alone (standard therapy) [see Clinical Studies (14.1) ] .
• In 2 active-controlled clinical trials in patients receiving moderately emetogenic chemotherapy (MEC) (Studies 3 and 4), EMEND in combination with ondansetron and dexamethasone (EMEND regimen) was compared to ondansetron and dexamethasone alone (standard therapy) [see Clinical Studies (14.2) ].
• The most common adverse reaction reported in patients who received MEC in pooled Studies 3 and 4 was dyspepsia (6% versus 4%).
• Across these 4 studies there were 1412 patients treated with the EMEND regimen during Cycle 1 of chemotherapy and 1099 of these patients continued into the Multiple-Cycle extension for up to 6 cycles of chemotherapy.
• The most common adverse reactions reported in patients who received HEC and MEC in pooled Studies 1, 2, 3 and 4 are listed in Table 5.
• Table 5:
• Most Common Adverse Reactions in Patients Receiving HEC and MEC from a Pooled Analysis of HEC and MEC Studies Reported in ≥ 3% of patients treated with the EMEND regimen and at a greater incidence than standard therapy.
• EMEND, ondansetron, and dexamethasone EMEND regimen (N=1412) Ondansetron and dexamethasone Standard therapy (N=1396) fatigue 13% 12% diarrhea 9% 8% asthenia 7% 6% dyspepsia 7% 5% abdominal pain 6% 5% hiccups 5% 3% white blood cell count decreased 4% 3% dehydration 3% 2% alanine aminotransferase increased 3% 2% In a pooled analysis of the HEC and MEC studies, less common adverse reactions reported in patients treated with the EMEND regimen are listed in Table 6.
• Table 6:
• Less Common Adverse Reactions in EMEND-Treated Patients from a Pooled Analysis of HEC and MEC Studies Reported in > 0.5% of patients treated with the EMEND regimen, at a greater incidence than standard therapy and not previously described in Table 5.
• Infection and Infestations oral candidiasis, pharyngitis Blood and the Lymphatic System Disorders anemia, febrile neutropenia, neutropenia, thrombocytopenia Metabolism and Nutrition Disorders decreased appetite, hypokalemia Psychiatric Disorders anxiety Nervous System Disorders dizziness, dysgeusia, peripheral neuropathy Cardiac Disorders palpitations Vascular Disorders flushing, hot flush Respiratory, Thoracic and Mediastinal Disorders cough, dyspnea, oropharyngeal pain Gastrointestinal Disorders dry mouth, eructation, flatulence, gastritis, gastroesophageal reflux disease, nausea, vomiting Skin and Subcutaneous Tissue Disorders alopecia, hyperhidrosis, rash Musculoskeletal and Connective Tissue Disorders musculoskeletal pain General Disorders and Administration Site Condition edema peripheral, malaise Investigations aspartate aminotransferase increased, blood alkaline phosphatase increased, blood sodium decreased, blood urea increased, proteinuria, weight decreased In an additional active-controlled clinical study in 1169 patients receiving EMEND and HEC, the adverse reactions were generally similar to that seen in the other HEC studies with EMEND.
• In another CINV study, Stevens-Johnson syndrome was reported as a serious adverse reaction in a patient receiving the EMEND regimen with cancer chemotherapy.
• Adverse reactions in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1.
• Pediatric Patients 6 Months to 17 Years of Age In a pooled analysis of 2 active-controlled clinical trials in pediatric patients aged 6 months to 17 years who received highly or moderately emetogenic cancer chemotherapy (Study 5 and a safety study, Study 6), EMEND in combination with ondansetron with or without dexamethasone (EMEND regimen) was compared to ondansetron with or without dexamethasone (control regimen).
• There were 184 patients treated with the EMEND regimen during Cycle 1 and 215 patients received open-label EMEND for up to 9 additional cycles of chemotherapy.
• In Cycle 1, the most common adverse reactions reported in pediatric patients treated with the EMEND regimen in pooled Studies 5 and 6 are listed in Table 7.
• Table 7:
• Most Common Adverse Reactions in EMEND-Treated Pediatric Patients in HEC and MEC Pooled Studies 5 and 6 Reported in ≥3% of patients treated with the EMEND regimen and at a greater incidence than control regimen.
• EMEND and ondansetron EMEND regimen (N=184) Ondansetron Control regimen (N=168) neutropenia 13% 11% headache 9% 5% diarrhea 6% 5% decreased appetite 5% 4% cough 5% 3% fatigue 5% 2% hemoglobin decreased 5% 4% dizziness 5% 1% hiccups 4% 1% Forty-nine patients were treated with ifosfamide chemotherapy in each arm.
• Two of the patients treated with ifosfamide in the aprepitant arm developed behavioral changes (agitation = 1; abnormal behavior = 1), whereas no patient treated with ifosfamide in the control arm developed behavioral changes.
• Aprepitant has the potential for increasing ifosfamide-mediated neurotoxicity through induction of CYP3A4 [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] .
• Non-CINV Studies Serious adverse reactions reported in adult patients receiving a non-recommended dosage of EMEND in non-CINV studies include single cases of each of the following:
• angioedema and urticaria, constipation, and sub-ileus.
• EMEND is only approved in the CINV population.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of EMEND.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Skin and subcutaneous tissue disorders:
• pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis.
• Immune system disorders:
• hypersensitivity reactions including anaphylactic reactions [see Contraindications (4) ] .
• Nervous system disorders:
• ifosfamide-induced neurotoxicity reported after EMEND and ifosfamide coadministration.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Hypersensitivity Reactions Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported in patients taking EMEND.
• Advise patients to stop taking EMEND and seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, or difficulty in breathing or swallowing.
• Drug Interactions Advise patients to discuss all medications they are taking, including other prescription, non-prescription medication or herbal products [see Contraindications (4) , Warnings and Precautions (5.1) ].
• Warfarin:
• Instruct patients on chronic warfarin therapy to follow instructions from their healthcare provider regarding blood draws to monitor their INR during the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of EMEND with each chemotherapy cycle [see Warnings and Precautions (5.2) ] .
• Hormonal Contraceptives:
• Advise patients that administration of EMEND may reduce the efficacy of hormonal contraceptives.
• Instruct patients to use effective alternative or back-up methods of contraception (such as condoms and spermicides) during treatment with EMEND and for 1 month following the last dose of EMEND [see Warnings and Precautions (5.3) , Use in Specific Populations (8.3) ] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS EMEND capsules:
• 80 mg and 125 mg ( 3 ) EMEND for oral suspension:
• 125 mg ( 3 ) EMEND capsules:
• 80 mg:
• white body and cap with "461" and "80 mg" printed radially in black ink on the body. 125 mg:
• white body and pink cap with "462" and "125 mg" printed radially in black ink on the body.
• EMEND for oral suspension:
• 125 mg as a pink to light pink powder in a single-use pouch with one 1 mL oral dosing dispenser, one 5 mL oral dosing dispenser, one cap and mixing cup.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 80-mg capsules:
• White, opaque, hard gelatin capsule with "461" and "80 mg" printed radially in black ink on the body.
• They are supplied as follows:
• NDC 0006-0461-02 unit-of-use BiPack of 2 Unit-of-use TriPack containing one 125-mg capsule and two 80-mg capsules. 125 mg-capsules:
• Opaque, hard gelatin capsule with white body and pink cap with “462” and “125 mg” printed radially in black ink on the body. 80-mg capsules:
• White, opaque, hard gelatin capsule with “461” and “80 mg” printed radially in black ink on the body.
• NDC 0006-3862-03. 125 mg for oral suspension:
• Pink to light pink powder, in a single-use pouch, packaged as a kit with one 1 mL oral dosing dispenser, one 5 mL oral dosing dispenser, one cap and one mixing cup.
• It is supplied as follows: NDC 0006-3066-03 – unit of use carton.
• Storage and Handling Capsules
• Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
• For Oral Suspension Store unopened pouch at 20-25°C (68-77°F); excursions permitted between 15-30°C (between 59-86°F).
• Store in the original container.
• Do not open pouch until ready for use.
• Once prepared, if suspension is not used immediately, store refrigerated [between 36°F-46°F (2°C-8°C)] for up to 72 hours prior to use.
• When ready to use, the mixture can be kept at room temperature [between 68°F-77°F (20°C-25°C)] for up to 3 hours.

Quoted from the official label, section “How Supplied”.

How to store it

• Capsules Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
• For Oral Suspension Store unopened pouch at 20-25°C (68-77°F); excursions permitted between 15-30°C (between 59-86°F).
• Store in the original container.
• Do not open pouch until ready for use.
• Once prepared, if suspension is not used immediately, store refrigerated [between 36°F-46°F (2°C-8°C)] for up to 72 hours prior to use.
• When ready to use, the mixture can be kept at room temperature [between 68°F-77°F (20°C-25°C)] for up to 3 hours.

Quoted from the official label, section “Storage and Handling”.

What is in it

• EMEND capsules contain the active ingredient, aprepitant.
• Aprepitant is a substance P/neurokinin 1 (NK 1 ) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R ,3 S )-2-[(1 R )-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H -1,2,4-triazol-3-one.
• Its empirical formula is C 23 H 21 F 7 N 4 O 3 , and its structural formula is:
• Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43.
• It is practically insoluble in water.
• Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile.
• Each capsule of EMEND for oral administration contains either 80 mg or 125 mg of aprepitant and the following inactive ingredients:
• sucrose, microcrystalline cellulose, hydroxypropyl cellulose and sodium lauryl sulfate.
• The capsule shell excipients are gelatin, titanium dioxide, and may contain sodium lauryl sulfate and silicon dioxide.
• The 125-mg capsule also contains red ferric oxide and yellow ferric oxide.
• Each pouch of EMEND for oral suspension 125 mg contains 125 mg of aprepitant and the following inactive ingredients:
• sucrose, lactose, hydroxypropyl cellulose, sodium lauryl sulfate, red iron oxide, and sodium stearyl fumarate.
• Chemical Structure

Quoted from the official label, section “Description”.

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Details

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).

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