darifenacin

Generic: darifenacin hydrobromide

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

darifenacin hydrobromide 7.5 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-431
Product ID 69097-431_99ca2704-b757-4f10-be5c-bd01dff69b10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207664
Listing Expiration 2026-12-31
Marketing Start 2016-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097431
Hyphenated Format 69097-431

Supplemental Identifiers

RxCUI
485421 485423
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 ANDA207664 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-02)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-15)
source: ndc

Packages (3)

69097-431-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-02) 69097-431-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-05) 69097-431-15 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-15)

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": "99ca2704-b757-4f10-be5c-bd01dff69b10", "openfda": {"unii": ["CR02EYQ8GV"], "rxcui": ["485421", "485423"], "spl_set_id": ["6e8470d1-c3e6-4644-b70a-aa47ddf79676"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-02)", "package_ndc": "69097-431-02", "marketing_start_date": "20160901"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-05)", "package_ndc": "69097-431-05", "marketing_start_date": "20160901"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-15)", "package_ndc": "69097-431-15", "marketing_start_date": "20160901"}], "brand_name": "Darifenacin", "product_id": "69097-431_99ca2704-b757-4f10-be5c-bd01dff69b10", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "69097-431", "generic_name": "Darifenacin Hydrobromide", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darifenacin", "active_ingredients": [{"name": "DARIFENACIN HYDROBROMIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA207664", "marketing_category": "ANDA", "marketing_start_date": "20160901", "listing_expiration_date": "20261231"}