Medicine
Promethazine 6.25 mg/5 mL syrup
Promethazine 6.25 mg/5 mL syrup is a generic prescription medicine for oral use, made by 4 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)
- Promethazine
- Brand
- Sold under the generic name
- Strength
- 6.25 mg/5 mL
- Dosage form
- Syrup
- Route
- Oral
- Packs
- 473 mL, 72 cup and 2 more
- Manufacturers
- Atlantic BiologicalsA-S Medication SolutionsCranbury PharmaceuticalsXttrium Laboratories
- 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 June 2012
- Identifiers
- RxCUI 992432DailyMed set ID c0a68671-407b-4840-9662-04f168cff1cb, 4f99bbd5-02f7-2fed-e063-6394a90a6355, 69934bbb-922c-4752-b253-f2f07340de8d +2NDC 50090-6431, 17856-4023, 17856-0059 +2Application ANDA091675, ANDA087953
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 |
|---|---|---|---|
| 473 mL in 1 bottle | 27808-051-02 | Cranbury Pharmaceuticals | 30 September 2021 |
| 473 mL in 1 bottle, plastic | 0116-4023-16 | Xttrium Laboratories | 7 April 2025 |
| 72 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose | 17856-0059-1 | Atlantic Biologicals | 13 November 2023 |
| 72 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 17856-4023-1 | Atlantic Biologicals | 20 April 2026 |
| 473 mL in 1 bottle | 50090-6431-0 | A-S Medication Solutions | 10 April 2023 |
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
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 6.25 mg/5 mL syrup 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.