bupivacaine hydrochloride injection, solution (51662-1638)

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride injection, solution

Generic Name bupivacaine hydrochloride injection, solution

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 51662-1638

Product ID 51662-1638_0f952dd8-92a8-2eb0-e063-6394a90a8c35

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207183

Listing Expiration 2026-12-31

Marketing Start 2016-05-13

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621638

Hyphenated Format 51662-1638

Supplemental Identifiers

RxCUI

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 injection, solution (source: ndc)

Generic Name bupivacaine hydrochloride injection, solution (source: ndc)

Application Number ANDA207183 (source: ndc)

Routes

PERINEURAL

source: ndc

Resolved Composition

Strengths

5 mg/mL

source: ndc

Packaging

25 POUCH in 1 CASE (51662-1638-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1638-2) / 50 mL in 1 VIAL, MULTI-DOSE

source: ndc

Packages (1)

51662-1638-3 25 POUCH in 1 CASE (51662-1638-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1638-2) / 50 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

bupivacaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

BUPIVACAINE HYDROCHLORIDE injection, solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["PERINEURAL"], "spl_id": "0f952dd8-92a8-2eb0-e063-6394a90a8c35", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1012404"], "spl_set_id": ["06c15208-c600-7173-e063-6394a90a2f94"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 CASE (51662-1638-3)  / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1638-2)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "51662-1638-3", "marketing_start_date": "20231002"}], "brand_name": "BUPIVACAINE HYDROCHLORIDE injection, solution", "product_id": "51662-1638_0f952dd8-92a8-2eb0-e063-6394a90a8c35", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "51662-1638", "generic_name": "BUPIVACAINE HYDROCHLORIDE injection, solution", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPIVACAINE HYDROCHLORIDE injection, solution", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA207183", "marketing_category": "ANDA", "marketing_start_date": "20160513", "listing_expiration_date": "20261231"}