Medicine
Ranitidine 300 mg tablet
Ranitidine 300 mg tablet is a generic prescription medicine for oral use, made by 3 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
Store at 15ºC to 30ºC (59ºF to 86ºF) in a dry place. Note to the Pharmacist…
Key facts
- Active ingredient (INN)
- Ranitidine
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 250 tablets, 30 tablets and 2 more
- Manufacturers
- Amneal Pharmaceuticals of New YorkAtland PharmaceuticalsRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store at 15ºC to 30ºC (59ºF to 86ºF) in a dry place. Note to the Pharmacist: Inform the patient after first opening, store the tablets in the original bottle for up to 3 months (90 days). Protect from light. *MULTISTIX is a registered trademark of Bayer Healthcare LLC.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A02BA02 Ranitidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 December 2009
- Identifiers
- RxCUI 198191, 198193DailyMed set ID 0fba6615-37c2-4ba6-b6e5-09599369a5bc, fcf27c99-8bd4-41fb-bff8-38fed9de76d9, b38a3332-5c54-453f-aeb7-070f830955c2NDC 64980-637, 71993-315, 53746-254Application ANDA211289, ANDA077824
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 53746-254-01 | Amneal Pharmaceuticals of New York | 16 December 2009 |
| 250 tablet in 1 bottle | 53746-254-02 | Amneal Pharmaceuticals of New York | 16 December 2009 |
| 30 tablet in 1 bottle | 53746-254-30 | Amneal Pharmaceuticals of New York | 16 December 2009 |
| 30 tablet in 1 bottle | 71993-315-30 | Atland Pharmaceuticals | 19 September 2026 |
| 30 tablet in 1 bottle | 64980-637-03 | Rising Pharma Holdings | 6 December 2025 |
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 9 June 1983 | 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 Ranitidine
Clinical summary
Ranitidine is a histamine-2 receptor antagonist indicated to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. It is available as tablets and capsules for oral use. MedsAcross supplies Ranitidine 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 RanitidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RANITIDINE prescribing information (Atland Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Ranitidine 300 mg tablet 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.