Package 83831-116-01

Brand: cyclophosphamide

Generic: cyclophosphamide
NDC Package

Package Facts

Identity

Package NDC 83831-116-01
Digits Only 8383111601
Product NDC 83831-116
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (83831-116-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2024-08-01
Brand cyclophosphamide
Generic cyclophosphamide
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "5fc45658-c2d9-41de-821f-ff6f40a469dd", "openfda": {"upc": ["0383831118046", "0383831117025", "0383831116011"], "unii": ["8N3DW7272P"], "rxcui": ["2644738", "2644751", "2644824"], "spl_set_id": ["6f593585-e0dd-48bc-bd2b-c6c787e0b98c"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83831-116-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83831-116-01", "marketing_start_date": "20240801"}], "brand_name": "Cyclophosphamide", "product_id": "83831-116_5fc45658-c2d9-41de-821f-ff6f40a469dd", "dosage_form": "INJECTION", "product_ndc": "83831-116", "generic_name": "Cyclophosphamide", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclophosphamide", "active_ingredients": [{"name": "CYCLOPHOSPHAMIDE", "strength": "500 mg/mL"}], "application_number": "NDA210852", "marketing_category": "NDA", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}