zoledronic acid

Generic: zoledronic acid

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

Drug Facts

Product Profile

Brand Name zoledronic acid
Generic Name zoledronic acid
Labeler accord healthcare inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 4 mg/5mL

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-242
Product ID 16729-242_40aa7571-f6b0-3f64-e063-6394a90ae2c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205279
Listing Expiration 2026-12-31
Marketing Start 2017-10-16

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729242
Hyphenated Format 16729-242

Supplemental Identifiers

RxCUI
351114
UPC
0316729242318
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 ANDA205279 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (16729-242-31) / 5 mL in 1 VIAL
source: ndc

Packages (1)

16729-242-31 1 VIAL in 1 CARTON (16729-242-31) / 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": "40aa7571-f6b0-3f64-e063-6394a90ae2c3", "openfda": {"upc": ["0316729242318"], "unii": ["6XC1PAD3KF"], "rxcui": ["351114"], "spl_set_id": ["3df715a1-2562-4374-a383-6edc33c6e52f"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (16729-242-31)  / 5 mL in 1 VIAL", "package_ndc": "16729-242-31", "marketing_start_date": "20171016"}], "brand_name": "Zoledronic acid", "product_id": "16729-242_40aa7571-f6b0-3f64-e063-6394a90ae2c3", "dosage_form": "INJECTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "16729-242", "generic_name": "zoledronic acid", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoledronic acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "4 mg/5mL"}], "application_number": "ANDA205279", "marketing_category": "ANDA", "marketing_start_date": "20171016", "listing_expiration_date": "20261231"}