Medicine
Promethegan 12.5 mg suppository
Promethegan 12.5 mg suppository is a prescription medicine containing Promethazine for rectal use, marketed by Cosette Pharmaceuticals, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store refrigerated between 2°-8°C (36°-46°F).
Key facts
- Active ingredient (INN)
- Promethazine
- Brand
- Promethegan
- Strength
- 12.5 mg
- Dosage form
- Suppository
- Route
- Rectal
- Packs
- 1000 suppositories, 12 suppositories
- Marketing authorisation holder
- Cosette Pharmaceuticals
- Manufacturer
- Cosette Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store refrigerated between 2°-8°C (36°-46°F).
- Cold chain
- Yes, shipped temperature controlled
- 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
- 28 February 2004
- Identifiers
- RxCUI 992441, 992445, 992454 +1DailyMed set ID 5f079815-f48b-8b21-2130-7f791d967c9aNDC 0713-0536Application ANDA040428
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1000 suppository in 1 box | 0713-0536-10 | Cosette Pharmaceuticals | 28 February 2004 |
| 12 suppository in 1 box | 0713-0536-12 | Cosette Pharmaceuticals | 28 February 2004 |
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 suppository.
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 Promethegan 12.5 mg suppository 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.