zoledronic acid

Generic: zoledronic acid

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zoledronic acid
Generic Name zoledronic acid
Labeler northstar rx llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 4 mg/5mL

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 72603-198
Product ID 72603-198_5499e3f9-5d5d-4eeb-a859-62cc967d468f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201783
Listing Expiration 2026-12-31
Marketing Start 2023-11-01

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603198
Hyphenated Format 72603-198

Supplemental Identifiers

RxCUI
351114
UPC
0372603198010
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 (72603-198-01) / 5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

72603-198-01 1 VIAL, GLASS in 1 CARTON (72603-198-01) / 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": "5499e3f9-5d5d-4eeb-a859-62cc967d468f", "openfda": {"upc": ["0372603198010"], "unii": ["6XC1PAD3KF"], "rxcui": ["351114"], "spl_set_id": ["3885488c-6b83-421b-afee-61abceb95634"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (72603-198-01)  / 5 mL in 1 VIAL, GLASS", "package_ndc": "72603-198-01", "marketing_start_date": "20231101"}], "brand_name": "Zoledronic acid", "product_id": "72603-198_5499e3f9-5d5d-4eeb-a859-62cc967d468f", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "72603-198", "generic_name": "Zoledronic acid", "labeler_name": "NORTHSTAR RX LLC", "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": "20231101", "listing_expiration_date": "20261231"}