bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form INJECTION, SOLUTION
Routes
INFILTRATION PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-753
Product ID 70069-753_2b24af95-6f20-4945-bf8c-742f1d6f2721
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217792
Listing Expiration 2026-12-31
Marketing Start 2023-11-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069753
Hyphenated Format 70069-753

Supplemental Identifiers

RxCUI
1012396 1012404
UPC
0370069753019 0370069752012
UNII
7TQO7W3VT8

Packaging Origin

Original Packager
true

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 ANDA217792 (source: ndc)
Routes
INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (70069-753-01) / 50 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (70069-753-10) / 50 mL in 1 VIAL
  • 25 VIAL in 1 CARTON (70069-753-25) / 50 mL in 1 VIAL
source: ndc

Packages (3)

70069-753-01 1 VIAL in 1 CARTON (70069-753-01) / 50 mL in 1 VIAL 70069-753-10 10 VIAL in 1 CARTON (70069-753-10) / 50 mL in 1 VIAL 70069-753-25 25 VIAL in 1 CARTON (70069-753-25) / 50 mL in 1 VIAL

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": ["INFILTRATION", "PERINEURAL"], "spl_id": "2b24af95-6f20-4945-bf8c-742f1d6f2721", "openfda": {"upc": ["0370069753019", "0370069752012"], "unii": ["7TQO7W3VT8"], "rxcui": ["1012396", "1012404"], "spl_set_id": ["bcaab86f-20f0-4482-8d73-e29b36dced58"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70069-753-01)  / 50 mL in 1 VIAL", "package_ndc": "70069-753-01", "marketing_start_date": "20240529"}, {"sample": false, "description": "10 VIAL in 1 CARTON (70069-753-10)  / 50 mL in 1 VIAL", "package_ndc": "70069-753-10", "marketing_start_date": "20240530"}, {"sample": false, "description": "25 VIAL in 1 CARTON (70069-753-25)  / 50 mL in 1 VIAL", "package_ndc": "70069-753-25", "marketing_start_date": "20231127"}], "brand_name": "Bupivacaine hydrochloride", "product_id": "70069-753_2b24af95-6f20-4945-bf8c-742f1d6f2721", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "70069-753", "generic_name": "Bupivacaine hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA217792", "marketing_category": "ANDA", "marketing_start_date": "20231127", "listing_expiration_date": "20261231"}