zoledronic acid

Generic: zoledronic acid

Labeler: bpi labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

zoledronic acid 4 mg/5mL

Manufacturer
BPI Labs LLC

Identifiers & Regulatory

Product NDC 54288-100
Product ID 54288-100_fd8bf083-6f6b-44db-bc6d-5368522b83d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207341
Listing Expiration 2026-12-31
Marketing Start 2018-04-02

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54288100
Hyphenated Format 54288-100

Supplemental Identifiers

RxCUI
351114
UPC
0354288100014
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 ANDA207341 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (54288-100-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

54288-100-01 1 VIAL in 1 CARTON (54288-100-01) / 5 mL in 1 VIAL

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": "fd8bf083-6f6b-44db-bc6d-5368522b83d1", "openfda": {"upc": ["0354288100014"], "unii": ["6XC1PAD3KF"], "rxcui": ["351114"], "spl_set_id": ["634e9d4b-e940-4743-ad39-794dad28d79b"], "manufacturer_name": ["BPI Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (54288-100-01)  / 5 mL in 1 VIAL", "package_ndc": "54288-100-01", "marketing_start_date": "20180402"}], "brand_name": "Zoledronic Acid", "product_id": "54288-100_fd8bf083-6f6b-44db-bc6d-5368522b83d1", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "54288-100", "generic_name": "zoledronic acid", "labeler_name": "BPI Labs LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoledronic Acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "4 mg/5mL"}], "application_number": "ANDA207341", "marketing_category": "ANDA", "marketing_start_date": "20180402", "listing_expiration_date": "20261231"}