Package 52605-068-10
Brand: darifenacin
Generic: darifenacin hydrobromidePackage Facts
Identity
Package NDC
52605-068-10
Digits Only
5260506810
Product NDC
52605-068
Description
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-10)
Marketing
Marketing Status
Brand
darifenacin
Generic
darifenacin hydrobromide
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "46abf1bc-3aaf-4d26-8f2b-b0340e9b32e4", "openfda": {"upc": ["0352605067194"], "unii": ["CR02EYQ8GV"], "rxcui": ["485421", "485423"], "spl_set_id": ["62a72d3e-3c33-4f2d-b3d0-2e014f704c63"], "manufacturer_name": ["POLYGEN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-10)", "package_ndc": "52605-068-10", "marketing_start_date": "20201201"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-13)", "package_ndc": "52605-068-13", "marketing_start_date": "20201201"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-19)", "package_ndc": "52605-068-19", "marketing_start_date": "20201201"}], "brand_name": "Darifenacin", "product_id": "52605-068_46abf1bc-3aaf-4d26-8f2b-b0340e9b32e4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "52605-068", "generic_name": "Darifenacin Hydrobromide", "labeler_name": "POLYGEN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darifenacin", "active_ingredients": [{"name": "DARIFENACIN HYDROBROMIDE", "strength": "15 mg/1"}], "application_number": "ANDA211045", "marketing_category": "ANDA", "marketing_start_date": "20201201", "listing_expiration_date": "20261231"}