bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: fosun pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler fosun pharma usa inc.
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION
Active Ingredients

bupivacaine hydrochloride 2.5 mg/mL

Manufacturer
Fosun Pharma USA Inc.

Identifiers & Regulatory

Product NDC 72266-263
Product ID 72266-263_3a9969ce-001f-2ab6-e063-6294a90ad921
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091487
Listing Expiration 2026-12-31
Marketing Start 2025-12-08

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72266263
Hyphenated Format 72266-263

Supplemental Identifiers

RxCUI
1724880 1725078
UNII
7TQO7W3VT8

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bupivacaine hydrochloride (source: ndc)
Generic Name bupivacaine hydrochloride (source: ndc)
Application Number ANDA091487 (source: ndc)
Routes
EPIDURAL INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (72266-263-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

72266-263-10 10 VIAL in 1 CARTON (72266-263-10) / 10 mL in 1 VIAL

Ingredients (1)

bupivacaine hydrochloride (2.5 mg/mL)

Linked Drug Pages (1)

Bupivacaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION"], "spl_id": "3a9969ce-001f-2ab6-e063-6294a90ad921", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1724880", "1725078"], "spl_set_id": ["3a996abe-0bb9-4590-e063-6394a90a0b60"], "manufacturer_name": ["Fosun Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (72266-263-10)  / 10 mL in 1 VIAL", "package_ndc": "72266-263-10", "marketing_start_date": "20251208"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "72266-263_3a9969ce-001f-2ab6-e063-6294a90ad921", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "72266-263", "generic_name": "Bupivacaine Hydrochloride", "labeler_name": "Fosun Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA091487", "marketing_category": "ANDA", "marketing_start_date": "20251208", "listing_expiration_date": "20261231"}