fesoterodine fumarate

Generic: fesoterodine fumarate

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fesoterodine fumarate
Generic Name fesoterodine fumarate
Labeler northstar rxllc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fesoterodine fumarate 8 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-414
Product ID 72603-414_2f97f9a3-4f2e-8409-e063-6394a90a7f94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204792
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603414
Hyphenated Format 72603-414

Supplemental Identifiers

RxCUI
810071 810077
UPC
0372603413014 0372603414011
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 ANDA204792 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-414-01)
source: ndc

Packages (1)

72603-414-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-414-01)

Ingredients (1)

fesoterodine fumarate (8 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": "2f97f9a3-4f2e-8409-e063-6394a90a7f94", "openfda": {"upc": ["0372603413014", "0372603414011"], "unii": ["EOS72165S7"], "rxcui": ["810071", "810077"], "spl_set_id": ["cb597206-1c75-4a4f-a17a-524a2010a4b9"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-414-01)", "package_ndc": "72603-414-01", "marketing_start_date": "20240501"}], "brand_name": "FESOTERODINE FUMARATE", "product_id": "72603-414_2f97f9a3-4f2e-8409-e063-6394a90a7f94", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "72603-414", "generic_name": "FESOTERODINE FUMARATE", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FESOTERODINE FUMARATE", "active_ingredients": [{"name": "FESOTERODINE FUMARATE", "strength": "8 mg/1"}], "application_number": "ANDA204792", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}