darifenacin

Generic: darifenacin

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

Drug Facts

Product Profile

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

darifenacin hydrobromide 15 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-224
Product ID 46708-224_70d8a245-0125-4c31-b941-2137d96c43c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207681
Listing Expiration 2026-12-31
Marketing Start 2017-12-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708224
Hyphenated Format 46708-224

Supplemental Identifiers

RxCUI
485421 485423
UPC
0346708224301 0346708223304
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 ANDA207681 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-224-08)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-90)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-91)
source: ndc

Packages (4)

46708-224-08 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-224-08) 46708-224-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-30) 46708-224-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-90) 46708-224-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-91)

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": "70d8a245-0125-4c31-b941-2137d96c43c3", "openfda": {"upc": ["0346708224301", "0346708223304"], "unii": ["CR02EYQ8GV"], "rxcui": ["485421", "485423"], "spl_set_id": ["da7c2732-232c-4e71-92d9-577ef8617f56"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-224-08)", "package_ndc": "46708-224-08", "marketing_start_date": "20171212"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-30)", "package_ndc": "46708-224-30", "marketing_start_date": "20171212"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-90)", "package_ndc": "46708-224-90", "marketing_start_date": "20171212"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-91)", "package_ndc": "46708-224-91", "marketing_start_date": "20171212"}], "brand_name": "DARIFENACIN", "product_id": "46708-224_70d8a245-0125-4c31-b941-2137d96c43c3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "46708-224", "generic_name": "DARIFENACIN", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DARIFENACIN", "active_ingredients": [{"name": "DARIFENACIN HYDROBROMIDE", "strength": "15 mg/1"}], "application_number": "ANDA207681", "marketing_category": "ANDA", "marketing_start_date": "20171212", "listing_expiration_date": "20261231"}