Medicine
Nalbuphine 100 mg/10 mL injection
Nalbuphine 100 mg/10 mL injection is a generic prescription medicine for intramuscular, intravenous, subconjunctival use, 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 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). Protect…
Key facts
- Active ingredient (INN)
- Nalbuphine
- Brand
- Sold under the generic name
- Strength
- 100 mg/10 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous, subconjunctival
- Packs
- 1 vial of 10 mL
- Manufacturer
- Henry Schein
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). Protect from excessive light. Store in carton until contents have been used.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N02AF02 Nalbuphine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 December 2025
- Identifiers
- RxCUI 904415DailyMed set ID 4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2dNDC 0404-9767Application ANDA216049
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 |
|---|---|---|---|
| 1 vial, multi-dose in 1 bag / 10 mL in 1 vial, multi-dose | 0404-9767-10 | Henry Schein | 11 December 2025 |
| 25 carton in 1 case / 1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 0409-1464-01 | — | 19 July 2005 |
| 1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 70069-661-10 | — | 26 September 2024 |
| 1 vial, multi-dose in 1 bag / 10 mL in 1 vial, multi-dose | 71872-7114-1 | — | 3 May 2018 |
| 1 vial, multi-dose in 1 bag / 10 mL in 1 vial, multi-dose | 71872-7331-1 | — | 15 November 2024 |
| 1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 51662-1420-1 | — | 29 October 2019 |
| 10 mL in 1 vial, multi-dose | 84549-464-01 | — | 27 August 2025 |
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 15 May 1979 | 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 Nalbuphine 100 mg/10 mL injection.
Other strengths and forms of Nalbuphine
Clinical summary
Nalbuphine is an opioid agonist/antagonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is available as injection for intramuscular, intravenous and subcutaneous use. MedsAcross supplies Nalbuphine 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 NalbuphineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nalbuphine Hydrochloride prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
Need Nalbuphine 100 mg/10 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.