Medicine
Fentanyl 50 mcg/1 mL injection
Fentanyl 50 mcg/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 20˚C to 25˚C (68˚F to 77˚F), excursions permitted to 15˚C to 30˚C…
Key facts
- Active ingredient (INN)
- Fentanyl
- Brand
- Sold under the generic name
- Strength
- 50 mcg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 vials of 1 mL, 10 syringes of 1 mL and 1 more
- Manufacturers
- Fresenius KabiHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20˚C to 25˚C (68˚F to 77˚F), excursions permitted to 15˚C to 30˚C (59˚F to 86˚F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N01AH01 Fentanyl
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 May 2019
- Identifiers
- RxCUI 1735003, 1735007, 1735008 +5DailyMed set ID 38d0c14a-a0c1-44cc-a939-0304eb8037d6, ce5db1c2-feb1-4ad2-847a-d02e865bd47e, 0c10e465-4117-48ba-a454-23ccb7a3fcc7NDC 63323-806, 0641-6248, 0641-6247 +1Application ANDA210762, NDA019101, ANDA212086
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 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 63323-806-01 | Fresenius Kabi | 3 May 2019 |
| 10 syringe in 1 carton / 1 mL in 1 syringe | 63323-808-11 | Fresenius Kabi | 30 September 2020 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0641-6247-25 | Hikma Pharmaceuticals | 18 March 2021 |
| 10 syringe, glass in 1 carton / 1 mL in 1 syringe, glass | 0641-6248-10 | Hikma Pharmaceuticals | 1 February 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.
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 Fentanyl
Clinical summary
Fentanyl is an opioid agonist indicated for analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. MedsAcross supplies Fentanyl 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 FentanylFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fentanyl Citrate prescribing information (Phlow) · U.S. National Library of Medicine, DailyMed
- Effentora: European public assessment report (EPAR) · European Medicines Agency
- Instanyl: European public assessment report (EPAR) · European Medicines Agency
Need Fentanyl 50 mcg/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.