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Medicine

Bupivacaine 125 mg/50 mL injection

Bupivacaine · Infiltration, perineural
Available on requestPrescription onlyUS FDAGeneric name

Bupivacaine 125 mg/50 mL injection is a generic prescription medicine for infiltration, perineural use, made by 11 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

Available on request

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 to…

Key facts

Active ingredient (INN)
Bupivacaine
Brand
Sold under the generic name
Strength
125 mg/50 mL
Dosage form
Injection
Route
Infiltration, perineural
Packs
1 vial of 50 mL, 25 vials of 50 mL, 10 vials of 50 mL and 14 more
Manufacturers
Anthea PharmaIndiaEugiaIndiaHealthFirstSomerset TherapeuticsMedical Purchasing SolutionsSportpharmHenry ScheinHikma PharmaceuticalsHospiraMeitheal Pharmaceuticals
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).
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
30 April 2005
Identifiers
RxCUI 1012396, 1012404, 1724786 +7DailyMed set ID a0f9a86f-fa55-4cbb-8273-5dcecd76d627, 4595c642-1869-436c-9550-8f9f255efd27, e391f807-7699-6d82-e053-2a95a90ab641 +11NDC 85766-305, 0143-9328, 51662-1592 +11Application ANDA207183, ANDA205141, NDA018304 +4

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.

PackCodeLabelerMarketed since
1 vial in 1 carton / 50 mL in 1 vial83854-038-01Anthea PharmaIndia11 September 2026
25 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose55150-249-50EugiaIndia13 May 2016
10 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose0143-9328-10Hikma Pharmaceuticals11 February 2021
25 vial, multi-dose in 1 tray / 50 mL in 1 vial, multi-dose0409-1160-01Hospira30 April 2005
1 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose71288-723-52Meitheal Pharmaceuticals23 June 2023
1 vial in 1 carton / 50 mL in 1 vial70069-752-01Somerset Therapeutics16 May 2024
10 vial in 1 carton / 50 mL in 1 vial70069-752-10Somerset Therapeutics30 May 2024
25 vial in 1 carton / 50 mL in 1 vial70069-752-25Somerset Therapeutics27 November 2023
25 pouch in 1 case / 1 vial, multi-dose in 1 pouch / 50 mL in 1 vial, multi-dose51662-1581-3HealthFirst10 July 2022
25 pouch in 1 case / 1 vial, multi-dose in 1 pouch / 50 mL in 1 vial, multi-dose51662-1592-3HealthFirst13 July 2022
25 pouch in 1 case / 1 vial, multi-dose in 1 pouch / 50 mL in 1 vial, multi-dose51662-1606-3HealthFirst1 August 2022
1 vial, multi-dose in 1 bag / 50 mL in 1 vial, multi-dose71872-7133-1Medical Purchasing Solutions30 March 2018
1 vial, multi-dose in 1 bag / 50 mL in 1 vial, multi-dose71872-7217-1Medical Purchasing Solutions16 July 2020
1 vial, multi-dose in 1 bag / 50 mL in 1 vial, multi-dose0404-9826-50Henry Schein3 December 2021
25 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose72603-279-25Northstar Rx16 December 2024
1 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose85766-305-01Sportpharm10 October 2026
25 vial, multi-dose in 1 carton / 50 mL in 1 vial, multi-dose85766-305-25Sportpharm10 October 2026
1 vial in 1 carton / 50 mL in 1 vial83270-168-01—29 January 2026
50 mL in 1 vial, multi-dose70594-116-01—1 August 2023

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 3 October 1972Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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 Bupivacaine 125 mg/50 mL injection.

Compare all 3

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 Bupivacaine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Bupivacaine 125 mg/50 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.