Package 82511-008-20
Brand: gemcitabine hydrochloride
Generic: gemcitabine hydrochloridePackage Facts
Identity
Package NDC
82511-008-20
Digits Only
8251100820
Product NDC
82511-008
Description
1 VIAL, SINGLE-USE in 1 CARTON (82511-008-20) / 5 mL in 1 VIAL, SINGLE-USE
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": "2b407956-8a90-221c-e063-6394a90a0057", "openfda": {"upc": ["0382511008202"], "unii": ["U347PV74IL"], "rxcui": ["1719000", "1719003"], "spl_set_id": ["a6ddaa2f-4c17-430f-a7cd-96b6662923f6"], "manufacturer_name": ["Teyro Labs Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (82511-008-20) / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "82511-008-20", "marketing_start_date": "20240808"}], "brand_name": "Gemcitabine hydrochloride", "product_id": "82511-008_2b407956-8a90-221c-e063-6394a90a0057", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "82511-008", "generic_name": "Gemcitabine hydrochloride", "labeler_name": "Teyro Labs Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemcitabine hydrochloride", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "200 mg/5mL"}], "application_number": "ANDA078759", "marketing_category": "ANDA", "marketing_start_date": "20240808", "listing_expiration_date": "20261231"}