Package 68083-148-01
Brand: gemcitabine hydrochloride
Generic: gemcitabine hydrochloridePackage Facts
Identity
Package NDC
68083-148-01
Digits Only
6808314801
Product NDC
68083-148
Description
1 VIAL in 1 CARTON (68083-148-01) / 5 mL in 1 VIAL
Marketing
Marketing Status
Brand
gemcitabine hydrochloride
Generic
gemcitabine hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "35c72954-279a-45fe-aa22-2b97e20b7b0d", "openfda": {"upc": ["0368083148010", "0368083149017"], "unii": ["U347PV74IL"], "rxcui": ["1719000", "1719003"], "spl_set_id": ["9f8fe5ba-943f-4f0a-9618-6083101faa28"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-148-01) / 5 mL in 1 VIAL", "package_ndc": "68083-148-01", "marketing_start_date": "20160201"}], "brand_name": "gemcitabine hydrochloride", "product_id": "68083-148_35c72954-279a-45fe-aa22-2b97e20b7b0d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68083-148", "generic_name": "gemcitabine hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gemcitabine hydrochloride", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "200 mg/5mL"}], "application_number": "ANDA204520", "marketing_category": "ANDA", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}