Medicine
Buprenorphine 0.324 mg/1 mL injection
Buprenorphine 0.324 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 4 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), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Buprenorphine
- Brand
- Sold under the generic name
- Strength
- 0.324 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 5 vials of 1 mL and 1 more
- Manufacturers
- Gland PharmaIndiaHikma PharmaceuticalsPar HealthSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [USP Controlled Room Temperature]. Protect from prolonged exposure to light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- ATC code
- N02AE01 Buprenorphine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 May 2005
- Identifiers
- RxCUI 238129DailyMed set ID 69ec3405-78ee-4cb4-9180-9bea937a8dcd, adc1167e-910e-4d7b-abdc-751d3df0c3dc, 74e40c51-853b-4e7f-b3cb-a27af29e1cbf +1NDC 68083-696, 0143-9246, 70069-027 +1Application ANDA221145, ANDA076931, ANDA219302 +1
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 |
|---|---|---|---|
| 5 vial in 1 carton / 1 mL in 1 vial | 68083-696-05 | Gland PharmaIndia | 15 October 2026 |
| 5 vial in 1 carton / 1 mL in 1 vial | 0143-9246-05 | Hikma Pharmaceuticals | 12 July 2019 |
| 5 vial in 1 carton / 1 mL in 1 vial | 42023-179-05 | Par Health | 30 July 2015 |
| 5 vial in 1 carton / 1 mL in 1 vial | 70069-027-05 | Somerset Therapeutics | 11 February 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.
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 Buprenorphine
Clinical summary
Buprenorphine is a partial opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, among other approved uses. MedsAcross supplies Buprenorphine 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 BuprenorphineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Buprenorphine prescribing information (Rhodes Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Buprenorphine Neuraxpharm: European public assessment report (EPAR) · European Medicines Agency
- Buvidal: European public assessment report (EPAR) · European Medicines Agency
Need Buprenorphine 0.324 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.