bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INFILTRATION PERINEURAL
Active Ingredients

bupivacaine hydrochloride 2.5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9328
Product ID 0143-9328_df5f611d-cfee-4378-9fc1-154b06ff68af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205141
Listing Expiration 2026-12-31
Marketing Start 2021-02-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439328
Hyphenated Format 0143-9328

Supplemental Identifiers

RxCUI
1012396 1012404
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 ANDA205141 (source: ndc)
Routes
INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9328-10) / 50 mL in 1 VIAL, MULTI-DOSE (0143-9328-01)
source: ndc

Packages (1)

0143-9328-10 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9328-10) / 50 mL in 1 VIAL, MULTI-DOSE (0143-9328-01)

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": "df5f611d-cfee-4378-9fc1-154b06ff68af", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1012396", "1012404"], "spl_set_id": ["4595c642-1869-436c-9550-8f9f255efd27"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (0143-9328-10)  / 50 mL in 1 VIAL, MULTI-DOSE (0143-9328-01)", "package_ndc": "0143-9328-10", "marketing_start_date": "20210211"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "0143-9328_df5f611d-cfee-4378-9fc1-154b06ff68af", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "0143-9328", "generic_name": "Bupivacaine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA205141", "marketing_category": "ANDA", "marketing_start_date": "20210211", "listing_expiration_date": "20261231"}