Medicine
Famotidine 40 mg/4 mL injection
Famotidine 40 mg/4 mL injection is a generic prescription medicine for intravenous use, made by 4 labelers, 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
If solution freezes, bring to room temperature, allow sufficient time to…
Key facts
- Active ingredient (INN)
- Famotidine
- Brand
- Sold under the generic name
- Strength
- 40 mg/4 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 4 mL, 25 vials of 4 mL and 2 more
- Manufacturers
- Hikma PharmaceuticalsFresenius KabiMylan InstitutionalSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- If solution freezes, bring to room temperature, allow sufficient time to solubilize all the components. Store Famotidine Injection, USP at 2º to 8ºC (36º to 46ºF). Protect from light. Although diluted Famotidine Injection, USP has been shown to be physically and chemically stable for 7 days at room temperature, there are no data on the maintenance of sterility after dilution.
- 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 April 2001
- Identifiers
- RxCUI 204441, 1743833DailyMed set ID e3b13e23-122b-4bd4-95cf-b5a14b7afc05, 2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c958, 1fdf16e5-145d-4c19-a318-fc6c10794b50 +1NDC 67457-448, 25021-754, 0641-6023 +1Application ANDA078641, ANDA075651, ANDA075488 +1
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial, multi-dose in 1 tray / 4 mL in 1 vial, multi-dose | 63323-738-09 | Fresenius Kabi | 19 July 2001 |
| 10 vial in 1 carton / 4 mL in 1 vial | 0641-6023-10 | Hikma Pharmaceuticals | 16 May 2023 |
| 25 vial in 1 carton / 4 mL in 1 vial | 0641-6023-25 | Hikma Pharmaceuticals | 16 April 2001 |
| 10 vial in 1 carton / 4 mL in 1 vial | 67457-448-43 | Mylan Institutional | 26 June 2008 |
| 10 vial in 1 carton / 4 mL in 1 vial | 25021-754-04 | Sagent Pharmaceuticals | 15 December 2024 |
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/4 mL injection 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.