darifenacin

Generic: darifenacin

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darifenacin
Generic Name darifenacin
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

darifenacin hydrobromide 7.5 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-202
Product ID 13668-202_fe809224-0deb-4a82-b454-054be6dd4931
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205209
Listing Expiration 2027-12-31
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 13668202
Hyphenated Format 13668-202

Supplemental Identifiers

RxCUI
485421 485423
UPC
0313668202304 0313668203301
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 ANDA205209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-90)
source: ndc

Packages (3)

13668-202-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-05) 13668-202-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-30) 13668-202-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-90)

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": "fe809224-0deb-4a82-b454-054be6dd4931", "openfda": {"upc": ["0313668202304", "0313668203301"], "unii": ["CR02EYQ8GV"], "rxcui": ["485421", "485423"], "spl_set_id": ["e84f1ae3-b9a2-4a15-a299-c75373891cc1"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-05)", "package_ndc": "13668-202-05", "marketing_start_date": "20161118"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-30)", "package_ndc": "13668-202-30", "marketing_start_date": "20161118"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-90)", "package_ndc": "13668-202-90", "marketing_start_date": "20161118"}], "brand_name": "Darifenacin", "product_id": "13668-202_fe809224-0deb-4a82-b454-054be6dd4931", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "13668-202", "generic_name": "Darifenacin", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darifenacin", "active_ingredients": [{"name": "DARIFENACIN HYDROBROMIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA205209", "marketing_category": "ANDA", "marketing_start_date": "20161118", "listing_expiration_date": "20271231"}