bupivacaine hcl

Generic: bupivacaine hcl

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

Drug Facts

Product Profile

Brand Name bupivacaine hcl
Generic Name bupivacaine hcl
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 51662-1588
Product ID 51662-1588_0ff9d690-ca06-4e75-e063-6394a90afd2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018304
Listing Expiration 2026-12-31
Marketing Start 2022-07-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621588
Hyphenated Format 51662-1588

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 hcl (source: ndc)
Generic Name bupivacaine hcl (source: ndc)
Application Number NDA018304 (source: ndc)
Routes
PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 POUCH in 1 CASE (51662-1588-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1588-2) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

51662-1588-3 25 POUCH in 1 CASE (51662-1588-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1588-2) / 50 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

bupivacaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

BUPIVACAINE HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["PERINEURAL"], "spl_id": "0ff9d690-ca06-4e75-e063-6394a90afd2a", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1012396", "1012404"], "spl_set_id": ["e391f807-7699-6d82-e053-2a95a90ab641"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 CASE (51662-1588-3)  / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1588-2)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "51662-1588-3", "marketing_start_date": "20220711"}], "brand_name": "BUPIVACAINE HCl", "product_id": "51662-1588_0ff9d690-ca06-4e75-e063-6394a90afd2a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "51662-1588", "generic_name": "BUPIVACAINE HCl", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPIVACAINE HCl", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA018304", "marketing_category": "NDA", "marketing_start_date": "20220711", "listing_expiration_date": "20261231"}