Package 50742-497-53

Brand: gemcitabine

Generic: gemcitabine
NDC Package

Package Facts

Identity

Package NDC 50742-497-53
Digits Only 5074249753
Product NDC 50742-497
Product ID 50742-497_fbfd32c8-27e6-4f09-a09c-5fce401b87c1
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (50742-497-53) / 52.6 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2023-07-01
Brand gemcitabine
Generic gemcitabine
Sample Package No

Linked Drug Pages (1)

GEMCITABINE ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fbfd32c8-27e6-4f09-a09c-5fce401b87c1", "openfda": {"upc": ["0350742496266", "0350742498055", "0350742497539"], "unii": ["U347PV74IL"], "rxcui": ["1720960", "1720975", "1720977"], "spl_set_id": ["a15f5d83-6ba1-4891-9e26-ce23ddaf68c7"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (50742-497-53)  / 52.6 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50742-497-53", "marketing_start_date": "20230701"}], "brand_name": "GEMCITABINE", "product_id": "50742-497_fbfd32c8-27e6-4f09-a09c-5fce401b87c1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "50742-497", "generic_name": "gemcitabine", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMCITABINE", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "38 mg/mL"}], "application_number": "ANDA210383", "marketing_category": "ANDA", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}