darifenacin

Generic: darifenacin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darifenacin
Generic Name darifenacin
Labeler bryant ranch prepack
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

darifenacin hydrobromide 15 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2571
Product ID 72162-2571_54c987d0-04fd-4fbc-8a3e-6d7c24132e48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205209
Listing Expiration 2026-12-31
Marketing Start 2016-11-18

Pharmacologic Class

Classes
cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721622571
Hyphenated Format 72162-2571

Supplemental Identifiers

RxCUI
485421
UNII
CR02EYQ8GV

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name darifenacin (source: ndc)
Generic Name darifenacin (source: ndc)
Application Number ANDA205209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2571-3)
source: ndc

Packages (1)

72162-2571-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2571-3)

Ingredients (1)

darifenacin hydrobromide (15 mg/1)

Linked Drug Pages (1)

Darifenacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "54c987d0-04fd-4fbc-8a3e-6d7c24132e48", "openfda": {"unii": ["CR02EYQ8GV"], "rxcui": ["485421"], "spl_set_id": ["5ac2cb5a-c0bb-40e2-95d5-1b91a13036c3"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2571-3)", "package_ndc": "72162-2571-3", "marketing_start_date": "20251117"}], "brand_name": "Darifenacin", "product_id": "72162-2571_54c987d0-04fd-4fbc-8a3e-6d7c24132e48", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "72162-2571", "generic_name": "Darifenacin", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darifenacin", "active_ingredients": [{"name": "DARIFENACIN HYDROBROMIDE", "strength": "15 mg/1"}], "application_number": "ANDA205209", "marketing_category": "ANDA", "marketing_start_date": "20161118", "listing_expiration_date": "20261231"}