bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler asclemed usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INTRACAUDAL PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-561
Product ID 76420-561_028b204a-e3a0-ea94-e063-6294a90ad70e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204842
Listing Expiration 2026-12-31
Marketing Start 2021-02-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420561
Hyphenated Format 76420-561

Supplemental Identifiers

RxCUI
1724880
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 ANDA204842 (source: ndc)
Routes
EPIDURAL INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, SINGLE-DOSE (76420-561-10)
source: ndc

Packages (1)

76420-561-10 10 mL in 1 VIAL, SINGLE-DOSE (76420-561-10)

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": "028b204a-e3a0-ea94-e063-6294a90ad70e", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1724880"], "spl_set_id": ["f37a19ad-5e69-44a8-947b-847df2106fb3"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, SINGLE-DOSE (76420-561-10)", "package_ndc": "76420-561-10", "marketing_start_date": "20230810"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "76420-561_028b204a-e3a0-ea94-e063-6294a90ad70e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "76420-561", "generic_name": "Bupivacaine Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA204842", "marketing_category": "ANDA", "marketing_start_date": "20210211", "listing_expiration_date": "20261231"}