Medicine
Cimetidine 400 mg tablet
Cimetidine 400 mg tablet is a generic prescription medicine for oral use, made by 9 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 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Cimetidine
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 90 tablets and 16 more
- Manufacturers
- Aurobindo PharmaIndiaPD-Rx PharmaceuticalsA-S Medication SolutionsBionpharmaTeva PharmaceuticalsChartwell RXMylan PharmaceuticalsNorthwind HealthProficient Rx
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A02BA01 Cimetidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 May 1994
- Identifiers
- RxCUI 197507, 197505, 197506 +1DailyMed set ID 28fd7158-a617-436a-8f5c-71ffbaafe527, 01997826-7ca1-473e-bfc9-075b14b58a35, 496e258d-a5fd-42da-9a86-73afc8be359b +7NDC 55289-581, 62135-632, 0093-8204 +7Application ANDA074246, ANDA074329, ANDA074151 +2
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, film coated in 1 bottle | 59651-825-01 | Aurobindo PharmaIndia | 12 November 2024 |
| 500 tablet, film coated in 1 bottle | 59651-825-05 | Aurobindo PharmaIndia | 12 November 2024 |
| 100 tablet, film coated in 1 bottle | 69452-325-20 | Bionpharma | 1 March 2025 |
| 500 tablet, film coated in 1 bottle | 69452-325-30 | Bionpharma | 1 March 2025 |
| 90 tablet, film coated in 1 bottle | 62135-632-90 | Chartwell RX | 15 August 2023 |
| 100 tablet, film coated in 1 bottle, plastic | 0378-0372-01 | Mylan Pharmaceuticals | 17 May 1994 |
| 100 tablet, film coated in 1 bottle | 0093-8204-01 | Teva Pharmaceuticals | 7 April 2004 |
| 500 tablet, film coated in 1 bottle | 0093-8204-05 | Teva Pharmaceuticals | 2 February 2004 |
| 30 tablet, film coated in 1 bottle | 50090-0500-0 | A-S Medication Solutions | 29 June 2016 |
| 60 tablet, film coated in 1 bottle | 50090-0500-1 | A-S Medication Solutions | 26 July 2016 |
| 30 tablet, film coated in 1 bottle | 50090-3574-0 | A-S Medication Solutions | 7 September 2018 |
| 60 tablet, film coated in 1 bottle | 50090-3574-1 | A-S Medication Solutions | 24 June 2019 |
| 40 tablet, film coated in 1 bottle, plastic | 51655-697-51 | Northwind Health | 1 April 2021 |
| 10 tablet, film coated in 1 bottle, plastic | 55289-581-10 | PD-Rx Pharmaceuticals | 2 November 2015 |
| 20 tablet, film coated in 1 bottle, plastic | 55289-581-20 | PD-Rx Pharmaceuticals | 2 November 2015 |
| 30 tablet, film coated in 1 bottle, plastic | 55289-581-30 | PD-Rx Pharmaceuticals | 2 November 2015 |
| 60 tablet, film coated in 1 bottle, plastic | 55289-581-60 | PD-Rx Pharmaceuticals | 2 November 2015 |
| 90 tablet, film coated in 1 bottle, plastic | 55289-581-90 | PD-Rx Pharmaceuticals | 2 November 2015 |
| 30 tablet, film coated in 1 bottle | 63187-333-30 | Proficient Rx | 1 January 2019 |
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 16 August 1977 | 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 Cimetidine
Clinical summary
Cimetidine is a histamine-2 receptor antagonist indicated to use cimetidine tablets at full dosage for longer than 6 to 8 weeks. It is available as tablets and oral solution. MedsAcross supplies Cimetidine 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 CimetidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cimetidine prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Cimetidine 400 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.