Medicine
Phenergan 50 mg/1 mL injection
Phenergan 50 mg/1 mL injection is a prescription medicine containing Promethazine for intramuscular use, marketed by Hikma 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.
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
- Phenergan
- Strength
- 50 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 25 ampules of 1 mL, 25 vials of 1 mL
- Marketing authorisation holder
- Hikma Pharmaceuticals
- Manufacturer
- Hikma Pharmaceuticals
- 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
- 19 September 1973
- Identifiers
- RxCUI 992460, 992462, 992858 +1DailyMed set ID 6f7e47cc-f823-4336-8107-f980e3049617, 481866da-a712-48a5-853f-8e84aacaab6dNDC 0641-6083, 0641-6085Application 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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 ampule in 1 carton / 1 mL in 1 ampule | 0641-6083-25 | Hikma Pharmaceuticals | 19 September 1973 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0641-6085-25 | Hikma Pharmaceuticals | 19 September 1973 |
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 Phenergan 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.