bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

bupivacaine hydrochloride 2.5 mg/mL

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 72603-279
Product ID 72603-279_4439cf55-3d69-4363-984f-dee716b14472
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216039
Marketing Start 2024-12-16
Marketing End 2026-11-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603279
Hyphenated Format 72603-279

Supplemental Identifiers

RxCUI
1012396 1012404
UPC
0372603279252 0372603287011 0372603287257 0372603279016
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 ANDA216039 (source: ndc)
Routes
INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (72603-279-25) / 50 mL in 1 VIAL, MULTI-DOSE (72603-279-01)
source: ndc

Packages (1)

72603-279-25 25 VIAL, MULTI-DOSE in 1 CARTON (72603-279-25) / 50 mL in 1 VIAL, MULTI-DOSE (72603-279-01)

Ingredients (1)

bupivacaine hydrochloride (2.5 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": "4439cf55-3d69-4363-984f-dee716b14472", "openfda": {"upc": ["0372603279252", "0372603287011", "0372603287257", "0372603279016"], "unii": ["7TQO7W3VT8"], "rxcui": ["1012396", "1012404"], "spl_set_id": ["adadc041-8d5e-4bf8-a89b-e227729a880d"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (72603-279-25)  / 50 mL in 1 VIAL, MULTI-DOSE (72603-279-01)", "package_ndc": "72603-279-25", "marketing_end_date": "20261117", "marketing_start_date": "20241216"}], "brand_name": "bupivacaine hydrochloride", "product_id": "72603-279_4439cf55-3d69-4363-984f-dee716b14472", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "72603-279", "generic_name": "bupivacaine hydrochloride", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bupivacaine hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA216039", "marketing_category": "ANDA", "marketing_end_date": "20261117", "marketing_start_date": "20241216"}