fesoterodine fumarate

Generic: fesoterodine fumarate

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fesoterodine fumarate
Generic Name fesoterodine fumarate
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fesoterodine fumarate 4 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-479
Product ID 68382-479_3e1e7df1-1de5-4500-bcd3-1c9ae36a60d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204946
Listing Expiration 2026-12-31
Marketing Start 2017-12-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382479
Hyphenated Format 68382-479

Supplemental Identifiers

RxCUI
810071 810077
UPC
0368382479068 0368382480064
UNII
EOS72165S7

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 fesoterodine fumarate (source: ndc)
Generic Name fesoterodine fumarate (source: ndc)
Application Number ANDA204946 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-06)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-16)
  • 10 BLISTER PACK in 1 CARTON (68382-479-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-479-30)
source: ndc

Packages (3)

68382-479-06 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-06) 68382-479-16 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-16) 68382-479-77 10 BLISTER PACK in 1 CARTON (68382-479-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-479-30)

Ingredients (1)

fesoterodine fumarate (4 mg/1)

Linked Drug Pages (1)

fesoterodine fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e1e7df1-1de5-4500-bcd3-1c9ae36a60d5", "openfda": {"upc": ["0368382479068", "0368382480064"], "unii": ["EOS72165S7"], "rxcui": ["810071", "810077"], "spl_set_id": ["8c68e918-b47b-466d-80bc-4f521aa74607"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-06)", "package_ndc": "68382-479-06", "marketing_start_date": "20171207"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-16)", "package_ndc": "68382-479-16", "marketing_start_date": "20171207"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-479-77)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-479-30)", "package_ndc": "68382-479-77", "marketing_start_date": "20171207"}], "brand_name": "fesoterodine fumarate", "product_id": "68382-479_3e1e7df1-1de5-4500-bcd3-1c9ae36a60d5", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "68382-479", "generic_name": "fesoterodine fumarate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fesoterodine fumarate", "active_ingredients": [{"name": "FESOTERODINE FUMARATE", "strength": "4 mg/1"}], "application_number": "ANDA204946", "marketing_category": "ANDA", "marketing_start_date": "20171207", "listing_expiration_date": "20261231"}