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
Routes
INTRAVENOUS
Active Ingredients

zoledronic acid 5 mg/100mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-135
Product ID 68083-135_d6e2e420-9322-4f59-9856-05104642fbc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204217
Listing Expiration 2027-12-31
Marketing Start 2016-09-15

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083135
Hyphenated Format 68083-135

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 ANDA204217 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/100mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (68083-135-01) / 100 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

68083-135-01 1 VIAL, GLASS in 1 CARTON (68083-135-01) / 100 mL in 1 VIAL, GLASS

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": "d6e2e420-9322-4f59-9856-05104642fbc2", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["705824"], "spl_set_id": ["824eaeee-6b3d-4d62-b268-77f8bd8e7f10"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (68083-135-01)  / 100 mL in 1 VIAL, GLASS", "package_ndc": "68083-135-01", "marketing_start_date": "20160915"}], "brand_name": "Zoledronic Acid", "product_id": "68083-135_d6e2e420-9322-4f59-9856-05104642fbc2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "68083-135", "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": "5 mg/100mL"}], "application_number": "ANDA204217", "marketing_category": "ANDA", "marketing_start_date": "20160915", "listing_expiration_date": "20271231"}