bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1396
Product ID 51662-1396_1b5824c7-c46a-48c6-e063-6394a90a22ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070597
Listing Expiration 2026-12-31
Marketing Start 2019-10-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621396
Hyphenated Format 51662-1396

Supplemental Identifiers

RxCUI
1012396 1012404
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 ANDA070597 (source: ndc)
Routes
PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 50 mL in 1 VIAL, MULTI-DOSE (51662-1396-1)
  • 25 POUCH in 1 CASE (51662-1396-3) / 1 mL in 1 POUCH (51662-1396-2)
source: ndc

Packages (2)

51662-1396-1 50 mL in 1 VIAL, MULTI-DOSE (51662-1396-1) 51662-1396-3 25 POUCH in 1 CASE (51662-1396-3) / 1 mL in 1 POUCH (51662-1396-2)

Ingredients (1)

bupivacaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

BUPIVACAINE HYDROCHLORIDE, 0.25% BUPIVACAINE HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["PERINEURAL"], "spl_id": "1b5824c7-c46a-48c6-e063-6394a90a22ce", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1012396", "1012404"], "spl_set_id": ["950d82b6-76a1-0c08-e053-2a95a90a3a92"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (51662-1396-1)", "package_ndc": "51662-1396-1", "marketing_start_date": "20191016"}, {"sample": false, "description": "25 POUCH in 1 CASE (51662-1396-3)  / 1 mL in 1 POUCH (51662-1396-2)", "package_ndc": "51662-1396-3", "marketing_start_date": "20201027"}], "brand_name": "BUPIVACAINE HYDROCHLORIDE", "product_id": "51662-1396_1b5824c7-c46a-48c6-e063-6394a90a22ce", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "51662-1396", "generic_name": "BUPIVACAINE HYDROCHLORIDE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPIVACAINE HYDROCHLORIDE", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA070597", "marketing_category": "ANDA", "marketing_start_date": "20191016", "listing_expiration_date": "20261231"}