bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler northstar rxllc
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL
Active Ingredients

bupivacaine hydrochloride 2.5 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-415
Product ID 72603-415_415a95a7-6a83-fcf0-e063-6294a90a266b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217821
Listing Expiration 2026-12-31
Marketing Start 2024-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603415
Hyphenated Format 72603-415

Supplemental Identifiers

RxCUI
1724786 1724787 1724880 1724884 1725078 1725082
UPC
0372603327014 0372603506013 0372603415018 0372603602012 0372603800012 0372603700015
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 ANDA217821 (source: ndc)
Routes
EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (72603-415-25) / 30 mL in 1 VIAL, SINGLE-DOSE (72603-415-01)
source: ndc

Packages (1)

72603-415-25 25 VIAL, SINGLE-DOSE in 1 CARTON (72603-415-25) / 30 mL in 1 VIAL, SINGLE-DOSE (72603-415-01)

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": ["EPIDURAL", "INFILTRATION", "INTRACAUDAL", "PERINEURAL"], "spl_id": "415a95a7-6a83-fcf0-e063-6294a90a266b", "openfda": {"upc": ["0372603327014", "0372603506013", "0372603415018", "0372603602012", "0372603800012", "0372603700015"], "unii": ["7TQO7W3VT8"], "rxcui": ["1724786", "1724787", "1724880", "1724884", "1725078", "1725082"], "spl_set_id": ["ee3b5bbe-4013-4682-b6ee-db86e7788077"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (72603-415-25)  / 30 mL in 1 VIAL, SINGLE-DOSE (72603-415-01)", "package_ndc": "72603-415-25", "marketing_start_date": "20241001"}], "brand_name": "BUPIVACAINE HYDROCHLORIDE", "product_id": "72603-415_415a95a7-6a83-fcf0-e063-6294a90a266b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "72603-415", "generic_name": "BUPIVACAINE HYDROCHLORIDE", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPIVACAINE HYDROCHLORIDE", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA217821", "marketing_category": "ANDA", "marketing_start_date": "20241001", "listing_expiration_date": "20261231"}