zoledronic acid

Generic: zoledronic acid

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zoledronic acid
Generic Name zoledronic acid
Labeler bluepoint laboratories
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 4 mg/5mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-610
Product ID 68001-610_3cb94fb2-f06f-69fc-e063-6294a90ad7b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201783
Listing Expiration 2026-12-31
Marketing Start 2024-02-28

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001610
Hyphenated Format 68001-610

Supplemental Identifiers

RxCUI
351114
UPC
0368001610254
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 ANDA201783 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (68001-610-25) / 5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

68001-610-25 1 VIAL, GLASS in 1 CARTON (68001-610-25) / 5 mL in 1 VIAL, GLASS

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": "3cb94fb2-f06f-69fc-e063-6294a90ad7b4", "openfda": {"upc": ["0368001610254"], "unii": ["6XC1PAD3KF"], "rxcui": ["351114"], "spl_set_id": ["f433c13c-dd8c-4dca-834e-a4ecf09d1eab"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (68001-610-25)  / 5 mL in 1 VIAL, GLASS", "package_ndc": "68001-610-25", "marketing_start_date": "20240228"}], "brand_name": "Zoledronic acid", "product_id": "68001-610_3cb94fb2-f06f-69fc-e063-6294a90ad7b4", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "68001-610", "generic_name": "Zoledronic acid", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoledronic acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "4 mg/5mL"}], "application_number": "ANDA201783", "marketing_category": "ANDA", "marketing_start_date": "20240228", "listing_expiration_date": "20261231"}