darifenacin

Generic: darifenacin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darifenacin
Generic Name darifenacin
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

darifenacin hydrobromide 15 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-862
Product ID 65862-862_389b20f0-64d5-46f6-bb3b-74feb1a9898b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206743
Listing Expiration 2026-12-31
Marketing Start 2016-09-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862862
Hyphenated Format 65862-862

Supplemental Identifiers

RxCUI
485421 485423
UPC
0365862862303
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 (source: ndc)
Application Number ANDA206743 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-05)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-30)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-90)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-99)
source: ndc

Packages (4)

65862-862-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-05) 65862-862-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-30) 65862-862-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-90) 65862-862-99 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-99)

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": "389b20f0-64d5-46f6-bb3b-74feb1a9898b", "openfda": {"upc": ["0365862862303"], "unii": ["CR02EYQ8GV"], "rxcui": ["485421", "485423"], "spl_set_id": ["28ed5b58-46dd-4140-a877-4b422f780a94"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-05)", "package_ndc": "65862-862-05", "marketing_start_date": "20160919"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-30)", "package_ndc": "65862-862-30", "marketing_start_date": "20160919"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-90)", "package_ndc": "65862-862-90", "marketing_start_date": "20160919"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-99)", "package_ndc": "65862-862-99", "marketing_start_date": "20160919"}], "brand_name": "Darifenacin", "product_id": "65862-862_389b20f0-64d5-46f6-bb3b-74feb1a9898b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "65862-862", "generic_name": "Darifenacin", "labeler_name": "Aurobindo Pharma Limited", "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"}