zoledronic acid

Generic: zoledronic acid

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zoledronic acid
Generic Name zoledronic acid
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 4 mg/5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-961
Product ID 63323-961_fd2c8ca9-52d9-4df8-bcd8-8569a4989cd0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202923
Listing Expiration 2026-12-31
Marketing Start 2014-09-04

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323961
Hyphenated Format 63323-961

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 ANDA202923 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (63323-961-98) / 5 mL in 1 VIAL
source: ndc

Packages (1)

63323-961-98 1 VIAL in 1 CARTON (63323-961-98) / 5 mL in 1 VIAL

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": "fd2c8ca9-52d9-4df8-bcd8-8569a4989cd0", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["351114"], "spl_set_id": ["f3f9de47-3d85-4d0c-a29e-1635cad3a970"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (63323-961-98)  / 5 mL in 1 VIAL", "package_ndc": "63323-961-98", "marketing_start_date": "20140904"}], "brand_name": "Zoledronic Acid", "product_id": "63323-961_fd2c8ca9-52d9-4df8-bcd8-8569a4989cd0", "dosage_form": "INJECTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "63323-961", "generic_name": "Zoledronic Acid", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoledronic Acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "4 mg/5mL"}], "application_number": "ANDA202923", "marketing_category": "ANDA", "marketing_start_date": "20140904", "listing_expiration_date": "20261231"}