Package 71288-117-54

Brand: gemcitabine

Generic: gemcitabine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 71288-117-54
Digits Only 7128811754
Product NDC 71288-117
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-54) / 52.6 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2020-12-11
Brand gemcitabine
Generic gemcitabine hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "c5bbcd6c-28a2-4db0-86dd-4c9ce60a434f", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1720960", "1720975", "1720977"], "spl_set_id": ["73ae04d8-38f9-4d3d-b0c2-71d22af1fc86"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-06)  / 5.26 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-117-06", "marketing_start_date": "20201211"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-28)  / 26.3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-117-28", "marketing_start_date": "20201211"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-54)  / 52.6 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-117-54", "marketing_start_date": "20201211"}], "brand_name": "Gemcitabine", "product_id": "71288-117_c5bbcd6c-28a2-4db0-86dd-4c9ce60a434f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "71288-117", "generic_name": "Gemcitabine hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemcitabine", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "38 mg/mL"}], "application_number": "ANDA212129", "marketing_category": "ANDA", "marketing_start_date": "20201211", "listing_expiration_date": "20261231"}