Medicine
Bupivacaine 50 mg/10 mL injection
Bupivacaine 50 mg/10 mL injection is a generic prescription medicine for epidural 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), excursions permitted between 15 °C…
Key facts
- Active ingredient (INN)
- Bupivacaine
- Brand
- Sold under the generic name
- Strength
- 50 mg/10 mL
- Dosage form
- Injection
- Route
- Epidural
- Packs
- 10 vials of 10 mL
- Manufacturers
- Fosun PharmaOnesource Specialty Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C to 30 °C (59 ° F to 86 °F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N01BB01 Bupivacaine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 January 2026
- Identifiers
- RxCUI 1724880, 1725078, 1724786 +3DailyMed set ID 3a996abe-0bb9-4590-e063-6394a90a0b60, 5c10e3a1-7806-40c7-afd2-4c420e141823NDC 72266-264, 83270-163Application ANDA091487
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 vial in 1 carton / 10 mL in 1 vial | 72266-264-10 | Fosun Pharma | 6 February 2026 |
| 10 vial in 1 carton / 10 mL in 1 vial | 83270-163-10 | Onesource Specialty Pharma | 29 January 2026 |
| 10 vial in 1 carton / 10 mL in 1 vial | 83854-039-10 | — | 11 September 2026 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 31722-276-31 | — | 27 March 2024 |
| 25 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 31722-276-32 | — | 27 March 2024 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 0143-9331-10 | — | 11 February 2021 |
| 25 vial, single-dose in 1 tray / 10 mL in 1 vial, single-dose | 0409-1162-01 | — | 8 March 2006 |
| 10 vial in 1 carton / 10 mL in 1 vial | 70594-117-02 | — | 1 June 2023 |
| 10 mL in 1 vial, single-dose | 76420-561-10 | — | 10 August 2023 |
| 10 mL in 1 vial, single-dose | 76420-579-10 | — | 9 August 2023 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 72603-506-10 | — | 1 October 2024 |
| 25 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 72603-506-25 | — | 1 October 2024 |
| 10 mL in 1 vial, single-dose | 85766-013-10 | — | 20 June 2025 |
| 25 vial, single-dose in 1 tray / 10 mL in 1 vial, single-dose | 85766-013-25 | — | 6 October 2026 |
| 25 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 55150-169-10 | — | 5 November 2013 |
| 10 mL in 1 vial, single-dose | 76420-008-10 | — | 16 January 2020 |
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
Alternatives
Other makers and brands of Bupivacaine 50 mg/10 mL injection.
Other strengths and forms of Bupivacaine
Clinical summary
Bupivacaine is an amide local anesthetic indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. MedsAcross supplies Bupivacaine 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 BupivacaineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Marcaine prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
- Exparel liposomal: European public assessment report (EPAR) · European Medicines Agency
Need Bupivacaine 50 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.