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
EPIDURAL RETROBULBAR
Active Ingredients

bupivacaine hydrochloride 7.5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9335
Product ID 0143-9335_1f5e723d-d695-4460-8142-713a5d621cff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204842
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 01439335
Hyphenated Format 0143-9335

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 ANDA204842 (source: ndc)
Routes
EPIDURAL RETROBULBAR
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9335-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0143-9335-01)
source: ndc

Packages (1)

0143-9335-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9335-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0143-9335-01)

Ingredients (1)

bupivacaine hydrochloride (7.5 mg/mL)

Linked Drug Pages (1)

Bupivacaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "RETROBULBAR"], "spl_id": "1f5e723d-d695-4460-8142-713a5d621cff", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1724786", "1724787", "1724880", "1724884", "1725078", "1725082"], "spl_set_id": ["8815c8c6-eed8-4afe-a5c1-44d2194025a3"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9335-10)  / 30 mL in 1 VIAL, SINGLE-DOSE (0143-9335-01)", "package_ndc": "0143-9335-10", "marketing_start_date": "20210211"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "0143-9335_1f5e723d-d695-4460-8142-713a5d621cff", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "0143-9335", "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": "7.5 mg/mL"}], "application_number": "ANDA204842", "marketing_category": "ANDA", "marketing_start_date": "20210211", "listing_expiration_date": "20261231"}