Package 83831-123-01

Brand: avgemsi

Generic: gemcitabine
NDC Package

Package Facts

Identity

Package NDC 83831-123-01
Digits Only 8383112301
Product NDC 83831-123
Product ID 83831-123_303c41a6-c142-4cd2-b133-9e610845d5bf
Description

1 VIAL, MULTI-DOSE in 1 CARTON (83831-123-01) / 26.3 mL in 1 VIAL, MULTI-DOSE

Marketing

Marketing Status
Marketed Since 2025-08-03
Brand avgemsi
Generic gemcitabine
Sample Package No

Linked Drug Pages (1)

AVGEMSI ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "303c41a6-c142-4cd2-b133-9e610845d5bf", "openfda": {"upc": ["0383831124016"], "unii": ["U347PV74IL"], "rxcui": ["2719761", "2719763"], "spl_set_id": ["e11eeff7-bcaf-4bf1-8da8-88138e01af84"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (83831-123-01)  / 26.3 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "83831-123-01", "marketing_start_date": "20250803"}], "brand_name": "AVGEMSI", "product_id": "83831-123_303c41a6-c142-4cd2-b133-9e610845d5bf", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "83831-123", "generic_name": "Gemcitabine", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AVGEMSI", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "38 mg/mL"}], "application_number": "NDA219920", "marketing_category": "NDA", "marketing_start_date": "20250803", "listing_expiration_date": "20261231"}