zoledronic acid

Generic: zoledronic acid

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zoledronic acid
Generic Name zoledronic acid
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid .05 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-830
Product ID 25021-830_dd7663fa-8a03-4717-a3fb-c4c03e6300e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202828
Listing Expiration 2026-12-31
Marketing Start 2013-03-02

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021830
Hyphenated Format 25021-830

Supplemental Identifiers

RxCUI
705824
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 ANDA202828 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 1 BAG in 1 CARTON (25021-830-82) / 100 mL in 1 BAG
  • 5 BAG in 1 CARTON (25021-830-87) / 100 mL in 1 BAG
source: ndc

Packages (2)

25021-830-82 1 BAG in 1 CARTON (25021-830-82) / 100 mL in 1 BAG 25021-830-87 5 BAG in 1 CARTON (25021-830-87) / 100 mL in 1 BAG

Ingredients (1)

zoledronic acid (.05 mg/mL)

Linked Drug Pages (1)

zoledronic acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "dd7663fa-8a03-4717-a3fb-c4c03e6300e8", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["705824"], "spl_set_id": ["164500d7-51cf-438a-8bee-7a7dce76ad7a"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 CARTON (25021-830-82)  / 100 mL in 1 BAG", "package_ndc": "25021-830-82", "marketing_start_date": "20130302"}, {"sample": false, "description": "5 BAG in 1 CARTON (25021-830-87)  / 100 mL in 1 BAG", "package_ndc": "25021-830-87", "marketing_start_date": "20250415"}], "brand_name": "zoledronic acid", "product_id": "25021-830_dd7663fa-8a03-4717-a3fb-c4c03e6300e8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "25021-830", "generic_name": "zoledronic acid", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "zoledronic acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": ".05 mg/mL"}], "application_number": "ANDA202828", "marketing_category": "ANDA", "marketing_start_date": "20130302", "listing_expiration_date": "20261231"}