Package 83634-801-05

Brand: zoledronic acid

Generic: zoledronic acid
NDC Package

Package Facts

Identity

Package NDC 83634-801-05
Digits Only 8363480105
Product NDC 83634-801
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (83634-801-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2025-01-15
Brand zoledronic acid
Generic zoledronic acid
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "1063bd7e-52b7-4df2-bd99-64929854a7d2", "openfda": {"unii": ["6XC1PAD3KF"], "rxcui": ["351114"], "spl_set_id": ["4b699dd8-d232-4bdb-88ce-9b42ed93e036"], "manufacturer_name": ["Avenacy Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83634-801-05)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83634-801-05", "marketing_start_date": "20250115"}], "brand_name": "Zoledronic Acid", "product_id": "83634-801_1063bd7e-52b7-4df2-bd99-64929854a7d2", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "83634-801", "generic_name": "zoledronic acid", "labeler_name": "Avenacy Inc.", "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": "20250115", "listing_expiration_date": "20261231"}