darifenacin

Generic: darifenacin hydrobromide

Labeler: polygen pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darifenacin
Generic Name darifenacin hydrobromide
Labeler polygen pharmaceuticals inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

darifenacin hydrobromide 7.5 mg/1

Manufacturer
POLYGEN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 52605-067
Product ID 52605-067_46abf1bc-3aaf-4d26-8f2b-b0340e9b32e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211045
Listing Expiration 2026-12-31
Marketing Start 2020-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52605067
Hyphenated Format 52605-067

Supplemental Identifiers

RxCUI
485421 485423
UPC
0352605067194
UNII
CR02EYQ8GV

Packaging Origin

Original Packager
true

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 hydrobromide (source: ndc)
Application Number ANDA211045 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-10)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-19)
source: ndc

Packages (2)

52605-067-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-10) 52605-067-19 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-19)

Ingredients (1)

darifenacin hydrobromide (7.5 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": "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 (52605-067-10)", "package_ndc": "52605-067-10", "marketing_start_date": "20201201"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-19)", "package_ndc": "52605-067-19", "marketing_start_date": "20201201"}], "brand_name": "Darifenacin", "product_id": "52605-067_46abf1bc-3aaf-4d26-8f2b-b0340e9b32e4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "52605-067", "generic_name": "Darifenacin Hydrobromide", "labeler_name": "POLYGEN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darifenacin", "active_ingredients": [{"name": "DARIFENACIN HYDROBROMIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA211045", "marketing_category": "ANDA", "marketing_start_date": "20201201", "listing_expiration_date": "20261231"}