fesoterodine fumarate

Generic: fesoterodine fumarate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fesoterodine fumarate
Generic Name fesoterodine fumarate
Labeler ascend laboratories, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fesoterodine fumarate 4 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-064
Product ID 67877-064_2fa76e78-8cb1-49ad-8f23-83ce759112be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204827
Listing Expiration 2026-12-31
Marketing Start 2022-06-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877064
Hyphenated Format 67877-064

Supplemental Identifiers

RxCUI
810071 810077
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 ANDA204827 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-90)
source: ndc

Packages (2)

67877-064-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-30) 67877-064-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-90)

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": "2fa76e78-8cb1-49ad-8f23-83ce759112be", "openfda": {"unii": ["EOS72165S7"], "rxcui": ["810071", "810077"], "spl_set_id": ["b1abd9cb-c480-437b-8531-e2de3e188363"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-30)", "package_ndc": "67877-064-30", "marketing_start_date": "20220609"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-90)", "package_ndc": "67877-064-90", "marketing_start_date": "20220609"}], "brand_name": "Fesoterodine Fumarate", "product_id": "67877-064_2fa76e78-8cb1-49ad-8f23-83ce759112be", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "67877-064", "generic_name": "Fesoterodine Fumarate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fesoterodine Fumarate", "active_ingredients": [{"name": "FESOTERODINE FUMARATE", "strength": "4 mg/1"}], "application_number": "ANDA204827", "marketing_category": "ANDA", "marketing_start_date": "20220609", "listing_expiration_date": "20261231"}