zoledronic acid

Generic: zoledronic acid

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zoledronic acid
Generic Name zoledronic acid
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 5 mg/100mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-619
Product ID 67457-619_f90dcc52-1a24-4e7f-88a8-851e70b90250
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203841
Listing Expiration 2027-12-31
Marketing Start 2017-05-19

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457619
Hyphenated Format 67457-619

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 ANDA203841 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/100mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (67457-619-10) / 100 mL in 1 VIAL
source: ndc

Packages (1)

67457-619-10 1 VIAL in 1 CARTON (67457-619-10) / 100 mL in 1 VIAL

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": "f90dcc52-1a24-4e7f-88a8-851e70b90250", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["705824"], "spl_set_id": ["1977d713-4cc7-405e-b4c1-a9a91635eff6"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (67457-619-10)  / 100 mL in 1 VIAL", "package_ndc": "67457-619-10", "marketing_start_date": "20170519"}], "brand_name": "Zoledronic Acid", "product_id": "67457-619_f90dcc52-1a24-4e7f-88a8-851e70b90250", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "67457-619", "generic_name": "Zoledronic Acid", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoledronic Acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "5 mg/100mL"}], "application_number": "ANDA203841", "marketing_category": "ANDA", "marketing_start_date": "20170519", "listing_expiration_date": "20271231"}