darifenacin

Generic: darifenacin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name darifenacin
Generic Name darifenacin
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

darifenacin hydrobromide 7.5 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-767
Product ID 16571-767_fd55c56a-79a8-4830-92d7-19f62bee0b5f
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 16571767
Hyphenated Format 16571-767

Supplemental Identifiers

RxCUI
485421 485423
UPC
0316571767038
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
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-03)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-09)
source: ndc

Packages (2)

16571-767-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-03) 16571-767-09 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-09)

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": "fd55c56a-79a8-4830-92d7-19f62bee0b5f", "openfda": {"upc": ["0316571767038"], "unii": ["CR02EYQ8GV"], "rxcui": ["485421", "485423"], "spl_set_id": ["e2aa9544-0136-463d-a73b-1a299534446a"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-03)", "package_ndc": "16571-767-03", "marketing_start_date": "20160919"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-09)", "package_ndc": "16571-767-09", "marketing_start_date": "20160919"}], "brand_name": "Darifenacin", "product_id": "16571-767_fd55c56a-79a8-4830-92d7-19f62bee0b5f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "16571-767", "generic_name": "Darifenacin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darifenacin", "active_ingredients": [{"name": "DARIFENACIN HYDROBROMIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA206743", "marketing_category": "ANDA", "marketing_start_date": "20160919", "listing_expiration_date": "20261231"}