Medicine
Fentanyl 100 mcg/2 mL injection
Fentanyl 100 mcg/2 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 5 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).
Key facts
- Active ingredient (INN)
- Fentanyl
- Brand
- Sold under the generic name
- Strength
- 100 mcg/2 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 vials of 2 mL, 20 syringes of 2 mL, 10 ampules of 2 mL and 5 more
- Manufacturers
- Fresenius KabiHikma PharmaceuticalsHospiraCivicaPhlow
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°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
- 11 July 1984
- Identifiers
- RxCUI 1735003, 1735007, 1735008 +7DailyMed set ID 1ed25b2c-334e-4021-ada1-3396f07630dc, 38d0c14a-a0c1-44cc-a939-0304eb8037d6, 0c10e465-4117-48ba-a454-23ccb7a3fcc7 +5NDC 0409-9093, 63323-806, 63323-810 +5Application NDA019115, ANDA210762, ANDA212086 +1
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 / 2 mL in 1 vial, single-dose | 63323-806-02 | Fresenius Kabi | 3 May 2019 |
| 20 syringe in 1 carton / 2 mL in 1 syringe | 63323-810-20 | Fresenius Kabi | 17 February 2023 |
| 25 vial in 1 carton / 2 mL in 1 vial | 0641-6027-25 | Hikma Pharmaceuticals | 11 July 1984 |
| 25 vial in 1 carton / 2 mL in 1 vial | 0641-6289-25 | Hikma Pharmaceuticals | 29 August 2025 |
| 10 ampule in 1 cello pack / 2 mL in 1 ampule | 0409-9093-11 | Hospira | 6 December 2016 |
| 25 vial, single-dose in 1 tray / 2 mL in 1 vial, single-dose | 0409-9094-22 | Hospira | 2 December 2010 |
| 25 vial in 1 carton / 2 mL in 1 vial | 81565-205-02 | Phlow | 11 January 2023 |
| 25 vial in 1 carton / 2 mL in 1 vial | 72572-170-25 | Civica | 10 December 2019 |
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 100 mcg/2 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.