Medicine
Butorphanol 1 mg/1 mL injection
Butorphanol 1 mg/1 mL injection is a generic prescription medicine for intramuscular, 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
Store at 20°C to 25°C (68°F to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Butorphanol
- Brand
- Sold under the generic name
- Strength
- 1 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 1 mL, 10 vials of 1 mL
- Manufacturers
- Hikma PharmaceuticalsHospira
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N02AF01 Butorphanol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 September 2005
- Identifiers
- RxCUI 886627, 1728351, 1728355DailyMed set ID 9822ca3f-aee2-46e5-8a96-495400e65d10, bded5531-8847-4576-9a29-3e44f979d2e0NDC 0409-1623, 0143-9864Application ANDA074626, ANDA078400
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 mL in 1 vial, single-dose | 0143-9864-10 | Hikma Pharmaceuticals | 1 May 2009 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 0409-1623-01 | Hospira | 23 September 2005 |
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 22 August 1978 | 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 Butorphanol
Clinical summary
Butorphanol is an opioid agonist/antagonist. It is available as injection and nasal spray for intramuscular and intravenous use. MedsAcross supplies Butorphanol 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 ButorphanolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Butorphanol Tartrate prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
Need Butorphanol 1 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.