Medicine
Promethazine 50 mg/1 mL injection
Promethazine 50 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 2 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 20º to 25ºC (68º to 77ºF). Protect from light.
Key facts
- Active ingredient (INN)
- Promethazine
- Brand
- Sold under the generic name
- Strength
- 50 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 ampules of 1 mL, 1 mL, 25 pouches of 1 mL
- Manufacturers
- HealthFirstXGen Pharmaceuticals DJB
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF). 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
- 30 January 2015
- Identifiers
- RxCUI 992858DailyMed set ID b6f6698f-f23c-452a-9b38-bbb96ab88ae4, 744bcc7b-a1b3-1b72-e053-2a91aa0a7c3aNDC 39822-5550, 51662-1248Application ANDA040737, ANDA083312
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 |
|---|---|---|---|
| 25 ampule in 1 carton / 1 mL in 1 ampule | 39822-5550-6 | XGen Pharmaceuticals DJB | 30 January 2015 |
| 1 mL in 1 ampule | 51662-1248-1 | HealthFirst | 26 August 2018 |
| 25 pouch in 1 case / 1 ampule in 1 pouch / 1 mL in 1 ampule | 51662-1248-3 | HealthFirst | 26 August 2018 |
| 25 vial, single-dose in 1 package / 1 mL in 1 vial, single-dose | 0641-0929-25 | — | 19 September 1973 |
| 25 ampule in 1 carton / 1 mL in 1 ampule | 0641-0949-35 | — | 19 September 1973 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0641-0956-25 | — | 19 September 1973 |
| 25 ampule in 1 package / 1 mL in 1 ampule | 0641-1496-35 | — | 19 September 1973 |
| 25 vial, single-dose in 1 package / 1 mL in 1 vial, single-dose | 50090-0879-0 | — | 28 November 2014 |
| 1 ampule in 1 bag / 1 mL in 1 ampule | 0404-9942-01 | — | 17 January 2022 |
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 50 mg/1 mL injection.
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 50 mg/1 mL injection 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.