fesoterodine fumarate

Generic: fesoterodine fumarate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fesoterodine fumarate
Generic Name fesoterodine fumarate
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fesoterodine fumarate 4 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-766
Product ID 65862-766_33d91059-f2d5-482f-a47f-b1dccb7c5b22
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205007
Listing Expiration 2026-12-31
Marketing Start 2022-06-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862766
Hyphenated Format 65862-766

Supplemental Identifiers

RxCUI
810071 810077
UPC
0365862766304 0365862767301
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 ANDA205007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-766-30)
source: ndc

Packages (1)

65862-766-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-766-30)

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": "33d91059-f2d5-482f-a47f-b1dccb7c5b22", "openfda": {"upc": ["0365862766304", "0365862767301"], "unii": ["EOS72165S7"], "rxcui": ["810071", "810077"], "spl_set_id": ["dc8f6158-3c2b-4ec0-a951-e04468b83bb1"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-766-30)", "package_ndc": "65862-766-30", "marketing_start_date": "20220617"}], "brand_name": "FESOTERODINE FUMARATE", "product_id": "65862-766_33d91059-f2d5-482f-a47f-b1dccb7c5b22", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "65862-766", "generic_name": "FESOTERODINE FUMARATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FESOTERODINE FUMARATE", "active_ingredients": [{"name": "FESOTERODINE FUMARATE", "strength": "4 mg/1"}], "application_number": "ANDA205007", "marketing_category": "ANDA", "marketing_start_date": "20220617", "listing_expiration_date": "20261231"}