Package 71288-117-92

Brand: gemcitabine

Generic: gemcitabine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 71288-117-92
Digits Only 7128811792
Product NDC 71288-117
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92) / 26.3 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": "be3f7738-022f-4b20-94f3-40f5337997c1", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1720960", "1720975", "1720977"], "spl_set_id": ["c0b1b715-9ff8-43ca-9e49-465f1f380084"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-91)  / 5.26 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-117-91", "marketing_start_date": "20201211"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92)  / 26.3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-117-92", "marketing_start_date": "20201211"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-93)  / 52.6 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-117-93", "marketing_start_date": "20201211"}], "brand_name": "Gemcitabine", "product_id": "71288-117_be3f7738-022f-4b20-94f3-40f5337997c1", "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"}