darifenacin

Generic: darifenacin

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

Drug Facts

Product Profile

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

darifenacin hydrobromide 15 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-277
Product ID 33342-277_2abbe156-e5ab-484c-aed7-fa4b5f06698d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207302
Listing Expiration 2026-12-31
Marketing Start 2017-07-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342277
Hyphenated Format 33342-277

Supplemental Identifiers

RxCUI
485421 485423
UPC
0333342277077 0333342276070 0333342277107 0333342276100
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 ANDA207302 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-07)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-10)
  • 10 BLISTER PACK in 1 CARTON (33342-277-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

33342-277-07 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-07) 33342-277-10 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-10) 33342-277-12 10 BLISTER PACK in 1 CARTON (33342-277-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "2abbe156-e5ab-484c-aed7-fa4b5f06698d", "openfda": {"upc": ["0333342277077", "0333342276070", "0333342277107", "0333342276100"], "unii": ["CR02EYQ8GV"], "rxcui": ["485421", "485423"], "spl_set_id": ["7ae60119-e22c-4806-a5d8-db7c9e8984a2"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-07)", "package_ndc": "33342-277-07", "marketing_start_date": "20170729"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-10)", "package_ndc": "33342-277-10", "marketing_start_date": "20170729"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-277-12)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "33342-277-12", "marketing_start_date": "20170729"}], "brand_name": "Darifenacin", "product_id": "33342-277_2abbe156-e5ab-484c-aed7-fa4b5f06698d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "33342-277", "generic_name": "Darifenacin", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darifenacin", "active_ingredients": [{"name": "DARIFENACIN HYDROBROMIDE", "strength": "15 mg/1"}], "application_number": "ANDA207302", "marketing_category": "ANDA", "marketing_start_date": "20170729", "listing_expiration_date": "20261231"}