Medicine
Ultiva 1 mg/mL powder for injection
Ultiva 1 mg/mL powder for injection is a prescription medicine containing Remifentanil for intravenous use, marketed by Mylan Institutional, 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
ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is…
Key facts
- Active ingredient (INN)
- Remifentanil
- Brand
- Ultiva
- Strength
- 1 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials and 3 more
- Marketing authorisation holder
- Mylan Institutional
- Manufacturer
- Mylan Institutional
- Origin register
- US FDA, United States
- Storage
- ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows: NDC Number Container Concentration Quantity 72078-034-01 3 mL Single-Dose Vial 1 mg lyophilized powder Box of 10 72078-035-02 5 mL Single-Dose Vial 2 mg lyophilized powder Box of 10 72078-036-05 10 mL Single-Dose Vial 5 mg lyophilized powder Box of 10 ULTIVA should be stored at 2° to 25°C (36° to 77°F).
- 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
- 15 April 2020
- Identifiers
- RxCUI 1729578, 1729581, 1729584 +3DailyMed set ID 8b4c8696-e23e-4c51-a4d2-babab5bd945a, 4dbcb8f9-1987-4b66-bd2f-d251fda0be10NDC 72078-036, 67457-914, 72078-035 +3Application NDA020630
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 |
|---|---|---|---|
| 10 vial, glass in 1 carton / 3 mL in 1 vial, glass | 67457-912-01 | Mylan Institutional | 15 April 2020 |
| 10 vial, glass in 1 carton / 5 mL in 1 vial, glass | 67457-913-02 | Mylan Institutional | 15 April 2020 |
| 10 vial, glass in 1 carton / 10 mL in 1 vial, glass | 67457-914-05 | Mylan Institutional | 15 April 2020 |
| 10 vial, glass in 1 carton / 3 mL in 1 vial, glass | 72078-034-01 | Mylan Institutional | 21 June 2023 |
| 10 vial, glass in 1 carton / 5 mL in 1 vial, glass | 72078-035-02 | Mylan Institutional | 18 September 2023 |
| 10 vial, glass in 1 carton / 10 mL in 1 vial, glass | 72078-036-05 | Mylan Institutional | 16 December 2024 |
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 Ultiva 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.