Package 16571-768-09
Brand: darifenacin
Generic: darifenacinPackage Facts
Identity
Package NDC
16571-768-09
Digits Only
1657176809
Product NDC
16571-768
Description
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-09)
Marketing
Marketing Status
Brand
darifenacin
Generic
darifenacin
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "fd55c56a-79a8-4830-92d7-19f62bee0b5f", "openfda": {"upc": ["0316571767038"], "unii": ["CR02EYQ8GV"], "rxcui": ["485421", "485423"], "spl_set_id": ["e2aa9544-0136-463d-a73b-1a299534446a"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-03)", "package_ndc": "16571-768-03", "marketing_start_date": "20160919"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-09)", "package_ndc": "16571-768-09", "marketing_start_date": "20160919"}], "brand_name": "Darifenacin", "product_id": "16571-768_fd55c56a-79a8-4830-92d7-19f62bee0b5f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "16571-768", "generic_name": "Darifenacin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darifenacin", "active_ingredients": [{"name": "DARIFENACIN HYDROBROMIDE", "strength": "15 mg/1"}], "application_number": "ANDA206743", "marketing_category": "ANDA", "marketing_start_date": "20160919", "listing_expiration_date": "20261231"}