zoledronic acid

Generic: zoledronic acid

Labeler: avenacy inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

zoledronic acid 4 mg/5mL

Manufacturer
Avenacy Inc.

Identifiers & Regulatory

Product NDC 83634-801
Product ID 83634-801_1063bd7e-52b7-4df2-bd99-64929854a7d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201783
Listing Expiration 2026-12-31
Marketing Start 2025-01-15

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634801
Hyphenated Format 83634-801

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 ANDA201783 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-801-05) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83634-801-05 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-801-05) / 5 mL in 1 VIAL, SINGLE-DOSE

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": "1063bd7e-52b7-4df2-bd99-64929854a7d2", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["351114"], "spl_set_id": ["4b699dd8-d232-4bdb-88ce-9b42ed93e036"], "manufacturer_name": ["Avenacy Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83634-801-05)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83634-801-05", "marketing_start_date": "20250115"}], "brand_name": "Zoledronic Acid", "product_id": "83634-801_1063bd7e-52b7-4df2-bd99-64929854a7d2", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "83634-801", "generic_name": "zoledronic acid", "labeler_name": "Avenacy Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoledronic Acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "4 mg/5mL"}], "application_number": "ANDA201783", "marketing_category": "ANDA", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}