zoledronic acid

Generic: zoledronic acid

Labeler: dr.reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zoledronic acid
Generic Name zoledronic acid
Labeler dr.reddy's laboratories inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 5 mg/100mL

Manufacturer
Dr.Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-331
Product ID 43598-331_d89899a3-8ada-0438-07b9-2164c640995a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091363
Listing Expiration 2026-12-31
Marketing Start 2013-08-19

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598331
Hyphenated Format 43598-331

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 ANDA091363 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/100mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE, GLASS (43598-331-11)
source: ndc

Packages (1)

43598-331-11 100 mL in 1 BOTTLE, GLASS (43598-331-11)

Ingredients (1)

zoledronic acid (5 mg/100mL)

Linked Drug Pages (1)

Zoledronic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d89899a3-8ada-0438-07b9-2164c640995a", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["705824"], "spl_set_id": ["c8e02635-4473-8ba2-248f-ced58dbeabce"], "manufacturer_name": ["Dr.Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE, GLASS (43598-331-11)", "package_ndc": "43598-331-11", "marketing_start_date": "20130819"}], "brand_name": "Zoledronic Acid", "product_id": "43598-331_d89899a3-8ada-0438-07b9-2164c640995a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "43598-331", "generic_name": "Zoledronic Acid", "labeler_name": "Dr.Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoledronic Acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "5 mg/100mL"}], "application_number": "ANDA091363", "marketing_category": "ANDA", "marketing_start_date": "20130819", "listing_expiration_date": "20261231"}