zoledronic acid

Generic: zoledronic acid

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

Drug Facts

Product Profile

Brand Name zoledronic acid
Generic Name zoledronic acid
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 4 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9642
Product ID 0143-9642_c3a41c1b-a9b0-4ad4-83b8-25e56e2c95fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202182
Listing Expiration 2026-12-31
Marketing Start 2013-06-03

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439642
Hyphenated Format 0143-9642

Supplemental Identifiers

RxCUI
351114
UNII
6XC1PAD3KF

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 zoledronic acid (source: ndc)
Generic Name zoledronic acid (source: ndc)
Application Number ANDA202182 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 5 mL in 1 VIAL (0143-9642-01)
source: ndc

Packages (1)

0143-9642-01 5 mL in 1 VIAL (0143-9642-01)

Ingredients (1)

zoledronic acid (4 mg/5mL)

Linked Drug Pages (1)

Zoledronic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c3a41c1b-a9b0-4ad4-83b8-25e56e2c95fe", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["351114"], "spl_set_id": ["784d33fa-0046-42eb-894b-3fc47dcfd4dc"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL (0143-9642-01)", "package_ndc": "0143-9642-01", "marketing_start_date": "20130603"}], "brand_name": "Zoledronic Acid", "product_id": "0143-9642_c3a41c1b-a9b0-4ad4-83b8-25e56e2c95fe", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "0143-9642", "generic_name": "zoledronic acid", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoledronic Acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "4 mg/5mL"}], "application_number": "ANDA202182", "marketing_category": "ANDA", "marketing_start_date": "20130603", "listing_expiration_date": "20261231"}