zoledronic acid

Generic: zoledronic acid

Labeler: dr.reddy's laboratories ltd
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 ltd
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 5 mg/100mL

Manufacturer
Dr.Reddy's Laboratories Ltd

Identifiers & Regulatory

Product NDC 55111-688
Product ID 55111-688_251add88-5c4f-2750-c713-744fcf3a60ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091363
Listing Expiration 2026-12-31
Marketing Start 2013-04-03

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111688
Hyphenated Format 55111-688

Supplemental Identifiers

RxCUI
705824
UPC
0355111688525
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 (55111-688-52)
source: ndc

Packages (1)

55111-688-52 100 mL in 1 BOTTLE, GLASS (55111-688-52)

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": "251add88-5c4f-2750-c713-744fcf3a60ba", "openfda": {"upc": ["0355111688525"], "unii": ["6XC1PAD3KF"], "rxcui": ["705824"], "spl_set_id": ["f94a5c9e-74bc-d09e-cd65-394b2a5de2ad"], "manufacturer_name": ["Dr.Reddy's Laboratories Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE, GLASS (55111-688-52)", "package_ndc": "55111-688-52", "marketing_start_date": "20130403"}], "brand_name": "Zoledronic Acid", "product_id": "55111-688_251add88-5c4f-2750-c713-744fcf3a60ba", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "55111-688", "generic_name": "Zoledronic Acid", "labeler_name": "Dr.Reddy's Laboratories Ltd", "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": "20130403", "listing_expiration_date": "20261231"}