Medicine
Nalbuphine 20 mg/1 mL injection
Nalbuphine 20 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous, subcutaneous 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℃ to 25°C (68℉ to 77°F). Protect from excessive light. Store in…
Key facts
- Active ingredient (INN)
- Nalbuphine
- Brand
- Sold under the generic name
- Strength
- 20 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous, subcutaneous
- Packs
- 10 ampules of 1 mL
- Manufacturers
- HospiraSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 20℃ to 25°C (68℉ to 77°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
- 31 December 2004
- Identifiers
- RxCUI 904415, 904440, 1866543 +1DailyMed set ID 6025e8d4-5083-4c3a-58a0-050e7b0b6150, a3221c05-5822-4ab8-b589-0e3939b91a68NDC 0409-1465, 70069-672Application ANDA070916, ANDA216050
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 ampule in 1 tray / 1 mL in 1 ampule | 0409-1465-01 | Hospira | 31 December 2004 |
| 10 ampule in 1 carton / 1 mL in 1 ampule | 70069-672-10 | Somerset Therapeutics | 25 September 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 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
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 20 mg/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.