bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INTRACAUDAL PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-162
Product ID 84549-162_463e0e03-4f19-1b80-e063-6394a90a4da7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070584
Listing Expiration 2026-12-31
Marketing Start 2005-11-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84549162
Hyphenated Format 84549-162

Supplemental Identifiers

RxCUI
1724884
UNII
7TQO7W3VT8

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 ANDA070584 (source: ndc)
Routes
EPIDURAL INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, SINGLE-DOSE (84549-162-02)
source: ndc

Packages (1)

84549-162-02 30 mL in 1 VIAL, SINGLE-DOSE (84549-162-02)

Ingredients (1)

bupivacaine hydrochloride (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", "INTRACAUDAL", "PERINEURAL"], "spl_id": "463e0e03-4f19-1b80-e063-6394a90a4da7", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1724884"], "spl_set_id": ["42c973e2-307b-924c-e063-6394a90a737a"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, SINGLE-DOSE (84549-162-02)", "package_ndc": "84549-162-02", "marketing_start_date": "20251010"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "84549-162_463e0e03-4f19-1b80-e063-6394a90a4da7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "84549-162", "generic_name": "BUPIVACAINE HYDROCHLORIDE", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA070584", "marketing_category": "ANDA", "marketing_start_date": "20051122", "listing_expiration_date": "20261231"}