Medicine
Promethazine 12.5 mg tablet
Promethazine 12.5 mg tablet is a generic prescription medicine for oral use, made by 12 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°C to 25°C (68°F to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Promethazine
- Brand
- Sold under the generic name
- Strength
- 12.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 51 more
- Manufacturers
- Zydus LifesciencesIndiaBryant Ranch PrepackAsclemedAmneal PharmaceuticalsKVK-TechAmneal Pharmaceuticals of New York12 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 December 2005
- Identifiers
- RxCUI 992438, 992447, 992475DailyMed set ID b4985d9d-1aa0-4b36-bc98-6a5410ad9bad, 7a137adf-39b7-4b14-80da-c3cac9ad562a, 0b5734b8-6a52-44ff-ac29-9a91a4335394 +12NDC 76420-678, 10702-002, 53746-745 +12Application ANDA040596, ANDA040712, ANDA091179
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
A sample of 40 packs from 12 labelers. The register lists 54 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 65841-040-01 | Zydus LifesciencesIndia | 14 December 2005 |
| 500 tablet in 1 bottle | 65841-040-05 | Zydus LifesciencesIndia | 14 December 2005 |
| 1000 tablet in 1 bottle | 65841-040-10 | Zydus LifesciencesIndia | 14 December 2005 |
| 100 tablet in 1 bottle | 68382-040-01 | Zydus LifesciencesIndia | 14 December 2005 |
| 500 tablet in 1 bottle | 68382-040-05 | Zydus LifesciencesIndia | 14 December 2005 |
| 1000 tablet in 1 bottle | 68382-040-10 | Zydus LifesciencesIndia | 14 December 2005 |
| 100 tablet in 1 bottle | 65162-745-10 | Amneal Pharmaceuticals | 3 March 2011 |
| 500 tablet in 1 bottle | 65162-745-50 | Amneal Pharmaceuticals | 3 March 2011 |
| 100 tablet in 1 bottle | 53746-745-01 | Amneal Pharmaceuticals of New York | 22 June 2022 |
| 100 tablet in 1 bottle | 10702-002-01 | KVK-Tech | 4 May 2007 |
| 1000 tablet in 1 bottle | 10702-002-10 | KVK-Tech | 4 May 2007 |
| 100 tablet in 1 bottle | 76420-678-01 | Asclemed | 26 February 2024 |
| 30 tablet in 1 bottle | 76420-678-30 | Asclemed | 26 February 2024 |
| 60 tablet in 1 bottle | 76420-678-60 | Asclemed | 26 February 2024 |
| 90 tablet in 1 bottle | 76420-678-90 | Asclemed | 26 February 2024 |
| 1000 tablet in 1 bottle | 87063-014-00 | Asclemed | 17 October 2025 |
| 100 tablet in 1 bottle | 87063-014-01 | Asclemed | 17 October 2025 |
| 500 tablet in 1 bottle | 87063-014-05 | Asclemed | 17 October 2025 |
| 10 tablet in 1 bottle | 87063-014-10 | Asclemed | 17 October 2025 |
| 20 tablet in 1 bottle | 87063-014-20 | Asclemed | 17 October 2025 |
| 30 tablet in 1 bottle | 87063-014-30 | Asclemed | 17 October 2025 |
| 60 tablet in 1 bottle | 87063-014-60 | Asclemed | 17 October 2025 |
| 90 tablet in 1 bottle | 87063-014-90 | Asclemed | 17 October 2025 |
| 30 tablet in 1 bottle | 63629-1591-0 | Bryant Ranch Prepack | 16 June 2015 |
| 12 tablet in 1 bottle | 63629-1591-1 | Bryant Ranch Prepack | 20 March 2006 |
| 4 tablet in 1 bottle | 63629-1591-2 | Bryant Ranch Prepack | 3 March 2023 |
| 2 tablet in 1 bottle | 63629-1591-3 | Bryant Ranch Prepack | 2 April 2024 |
| 6 tablet in 1 bottle | 63629-1591-5 | Bryant Ranch Prepack | 21 February 2012 |
| 10 tablet in 1 bottle | 63629-1591-6 | Bryant Ranch Prepack | 17 July 2009 |
| 40 tablet in 1 bottle | 63629-1591-7 | Bryant Ranch Prepack | 1 March 2013 |
| 20 tablet in 1 bottle | 63629-1591-8 | Bryant Ranch Prepack | 21 March 2013 |
| 60 tablet in 1 bottle | 63629-1591-9 | Bryant Ranch Prepack | 14 October 2014 |
| 30 tablet in 1 bottle | 71335-0989-0 | Bryant Ranch Prepack | 3 January 2019 |
| 12 tablet in 1 bottle | 71335-0989-1 | Bryant Ranch Prepack | 9 July 2024 |
| 4 tablet in 1 bottle | 71335-0989-2 | Bryant Ranch Prepack | 9 July 2024 |
| 2 tablet in 1 bottle | 71335-0989-3 | Bryant Ranch Prepack | 9 July 2024 |
| 6 tablet in 1 bottle | 71335-0989-5 | Bryant Ranch Prepack | 9 July 2024 |
| 10 tablet in 1 bottle | 71335-0989-6 | Bryant Ranch Prepack | 1 December 2021 |
| 40 tablet in 1 bottle | 71335-0989-7 | Bryant Ranch Prepack | 9 July 2024 |
| 20 tablet in 1 bottle | 71335-0989-8 | Bryant Ranch Prepack | 9 July 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 29 March 1951 | 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
Alternatives
Other makers and brands of Promethazine 12.5 mg tablet.
Other strengths and forms of Promethazine
Clinical summary
Promethazine is a phenothiazine. It is available as tablets, injection and suppositories for oral, intramuscular and intravenous use. MedsAcross supplies Promethazine 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 PromethazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PROMETHAZINE HYDROCHLORIDE prescribing information (KVK-Tech) · U.S. National Library of Medicine, DailyMed
Need Promethazine 12.5 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.