Medicine
Cimetidine 300 mg/5 mL oral solution
Cimetidine 300 mg/5 mL oral solution 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 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Cimetidine
- Brand
- Sold under the generic name
- Strength
- 300 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 2 trays, 237 mL and 1 more
- Manufacturers
- Chartwell RXChartwell Governmental & Specialty RXPAI Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- 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
- 22 December 1994
- Identifiers
- RxCUI 212787DailyMed set ID e40bb1f6-338a-42e7-9217-8c32d14ccfd3, b8b50bd9-bc1b-4da5-96c5-8eb917c8937f, d1d73350-4e7e-428a-90a5-6000fd373a4fNDC 68999-809, 0121-1025, 62135-809Application ANDA074251, ANDA074664
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 |
|---|---|---|---|
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 68999-809-24 | Chartwell Governmental & Specialty RX | 23 October 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 62135-809-24 | Chartwell RX | 22 October 2024 |
| 237 mL in 1 bottle | 62135-809-37 | Chartwell RX | 6 May 2024 |
| 237 mL in 1 bottle | 0121-1025-08 | PAI Pharma | 9 January 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 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 300 mg/5 mL 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.