Medicine
Famotidine 40 mg/5 mL powder for oral solution
Famotidine 40 mg/5 mL powder for oral solution is a generic prescription medicine for oral use, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Protect from freezing. Store famotidine for oral suspension dry powder and…
Key facts
- Active ingredient (INN)
- Famotidine
- Brand
- Sold under the generic name
- Strength
- 40 mg/5 mL
- Dosage form
- Powder for oral solution
- Route
- Oral
- Packs
- 1 bottle
- Manufacturer
- Akorn
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store famotidine for oral suspension dry powder and constituted suspension at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A02BA03 Famotidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 March 2016
- Identifiers
- DailyMed set ID 354a5a02-45cb-4ab0-88ee-6635d5a43b01NDC 50383-913Application ANDA201995
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, glass in 1 carton / 50 mL in 1 bottle, glass | 50383-913-40 | Akorn | 16 March 2016 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 October 1986 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Famotidine
Clinical summary
Famotidine is a histamine-2 receptor antagonist indicated in hospitalized adults, or as an alternative to oral famotidine in adults, for the treatment of active duodenal ulcer (DU), among other approved uses. MedsAcross supplies Famotidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about FamotidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Famotidine prescribing information (Sagent Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Famotidine 40 mg/5 mL powder for oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.