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 67457-794
Product ID 67457-794_b6b103d8-2eaa-4de8-a501-547f977cffd3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205254
Listing Expiration 2027-12-31
Marketing Start 2018-06-05

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457794
Hyphenated Format 67457-794

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 ANDA205254 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/100mL
source: ndc
Packaging
  • 1 BAG in 1 POUCH (67457-794-10) / 100 mL in 1 BAG
source: ndc

Packages (1)

67457-794-10 1 BAG in 1 POUCH (67457-794-10) / 100 mL in 1 BAG

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": "b6b103d8-2eaa-4de8-a501-547f977cffd3", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["705824"], "spl_set_id": ["80006f10-85a3-4390-b5dc-3b2097134f3d"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 POUCH (67457-794-10)  / 100 mL in 1 BAG", "package_ndc": "67457-794-10", "marketing_start_date": "20180605"}], "brand_name": "Zoledronic Acid", "product_id": "67457-794_b6b103d8-2eaa-4de8-a501-547f977cffd3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "67457-794", "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": "ANDA205254", "marketing_category": "ANDA", "marketing_start_date": "20180605", "listing_expiration_date": "20271231"}