Package 16714-909-01
Brand: gemcitabine
Generic: gemcitabine hydrochloridePackage Facts
Identity
Package NDC
16714-909-01
Digits Only
1671490901
Product NDC
16714-909
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (16714-909-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
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": "3907fd14-53af-499a-8334-94adb74142e0", "openfda": {"upc": ["0316714930015"], "unii": ["U347PV74IL"], "rxcui": ["1719000", "1719003"], "spl_set_id": ["5af49a48-f1c0-467d-b5da-ac9f1ae8e34c"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (16714-909-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "16714-909-01", "marketing_start_date": "20181101"}], "brand_name": "GEMCITABINE", "product_id": "16714-909_3907fd14-53af-499a-8334-94adb74142e0", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "16714-909", "generic_name": "GEMCITABINE HYDROCHLORIDE", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMCITABINE", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA091365", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}