zoledronic acid

Generic: zoledronic acid

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zoledronic acid
Generic Name zoledronic acid
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 4 mg/5mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-116
Product ID 68083-116_c08f4eee-1566-4493-83f7-48fa1319a234
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202930
Listing Expiration 2026-12-31
Marketing Start 2013-09-20

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083116
Hyphenated Format 68083-116

Supplemental Identifiers

RxCUI
351114
UPC
0368083615017 0368083116019
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 ANDA202930 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-116-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

68083-116-01 1 VIAL in 1 CARTON (68083-116-01) / 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": "c08f4eee-1566-4493-83f7-48fa1319a234", "openfda": {"upc": ["0368083615017", "0368083116019"], "unii": ["6XC1PAD3KF"], "rxcui": ["351114"], "spl_set_id": ["7a5e8962-7c4b-40bb-ad69-0c3edb0338af"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-116-01)  / 5 mL in 1 VIAL", "package_ndc": "68083-116-01", "marketing_start_date": "20130920"}], "brand_name": "Zoledronic Acid", "product_id": "68083-116_c08f4eee-1566-4493-83f7-48fa1319a234", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "68083-116", "generic_name": "zoledronic acid", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoledronic Acid", "active_ingredients": [{"name": "ZOLEDRONIC ACID", "strength": "4 mg/5mL"}], "application_number": "ANDA202930", "marketing_category": "ANDA", "marketing_start_date": "20130920", "listing_expiration_date": "20261231"}