bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: meitheal pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler meitheal pharmaceuticals inc
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INTRACAUDAL PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 71288-724
Product ID 71288-724_b085b86e-d32f-494e-8a4a-3080ff240109
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216040
Listing Expiration 2026-12-31
Marketing Start 2023-12-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288724
Hyphenated Format 71288-724

Supplemental Identifiers

RxCUI
1724786 1724787 1724880 1724884 1725078 1725082
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 ANDA216040 (source: ndc)
Routes
EPIDURAL INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-724-11) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-724-11 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-724-11) / 10 mL in 1 VIAL, SINGLE-DOSE

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": ["EPIDURAL", "INTRACAUDAL", "PERINEURAL"], "spl_id": "b085b86e-d32f-494e-8a4a-3080ff240109", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1724786", "1724787", "1724880", "1724884", "1725078", "1725082"], "spl_set_id": ["daec9ee4-b666-485e-a153-4b5e5acc48a1"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-724-11)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-724-11", "marketing_start_date": "20231227"}], "brand_name": "bupivacaine hydrochloride", "product_id": "71288-724_b085b86e-d32f-494e-8a4a-3080ff240109", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "71288-724", "generic_name": "bupivacaine hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bupivacaine hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA216040", "marketing_category": "ANDA", "marketing_start_date": "20231227", "listing_expiration_date": "20261231"}