Medicine
Remifentanil 1 mg/mL powder for injection
Remifentanil 1 mg/mL powder for injection is a generic prescription medicine for 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
Remifentanil Hydrochloride for injection, for intravenous use, is supplied as…
Key facts
- Active ingredient (INN)
- Remifentanil
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials and 4 more
- Manufacturers
- Fresenius KabiHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Remifentanil Hydrochloride for injection, for intravenous use, is supplied as follows: NDC Number Strength Container Quantity 0143-9391-10 1 mg per vial 3 mL Vial Packaged in cartons of 10 0143-9392-10 2 mg per vial 5 mL Vial Packaged in cartons of 10 0143-9393-10 5 mg per vial 10 mL Vial Packaged in cartons of 10 Remifentanil Hydrochloride for injection should be stored at 2° to 25°C (36° to…
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N01AH06 Remifentanil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 January 2018
- Identifiers
- RxCUI 1729578, 1729584, 1729710DailyMed set ID 9d289052-1eb6-4ba2-a3ca-d2e542a052ae, d2374b84-81c9-44f9-a4a9-1071281b2531, 5b8025d2-3424-477b-9cff-3990a98c2a65NDC 0143-9392, 63323-724, 63323-725 +3Application ANDA210594, ANDA206223
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 |
|---|---|---|---|
| 10 vial, single-dose in 1 carton / 3 mL in 1 vial, single-dose | 63323-723-03 | Fresenius Kabi | 19 January 2018 |
| 10 vial, single-dose in 1 carton / 3 mL in 1 vial, single-dose | 63323-723-06 | Fresenius Kabi | 19 January 2018 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 63323-724-05 | Fresenius Kabi | 19 January 2018 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 63323-725-10 | Fresenius Kabi | 19 January 2018 |
| 10 vial in 1 carton / 3 mL in 1 vial | 0143-9391-10 | Hikma Pharmaceuticals | 15 May 2021 |
| 10 vial in 1 carton / 5 mL in 1 vial | 0143-9392-10 | Hikma Pharmaceuticals | 15 May 2021 |
| 10 vial in 1 carton / 10 mL in 1 vial | 0143-9393-10 | Hikma Pharmaceuticals | 15 May 2021 |
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 12 July 1996 | 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 Remifentanil 1 mg/mL powder for injection.
Clinical summary
Remifentanil is an opioid agonist indicated for intravenous (IV) administration, among other approved uses. It is available as powder for injection for intravenous use. MedsAcross supplies Remifentanil 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 RemifentanilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ultiva prescribing information (Mylan Institutional) · U.S. National Library of Medicine, DailyMed
Need Remifentanil 1 mg/mL powder for 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.