fesoterodine fumarate

Generic: fesoterodine fumarate

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fesoterodine fumarate 8 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-034
Product ID 31722-034_2f836bf8-7034-db2e-e063-6394a90a3a3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204792
Listing Expiration 2026-12-31
Marketing Start 2024-01-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722034
Hyphenated Format 31722-034

Supplemental Identifiers

RxCUI
810071 810077
UPC
0331722033305 0331722034302
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 (31722-034-30)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-034-90)
source: ndc

Packages (2)

31722-034-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-034-30) 31722-034-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-034-90)

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": "2f836bf8-7034-db2e-e063-6394a90a3a3e", "openfda": {"upc": ["0331722033305", "0331722034302"], "unii": ["EOS72165S7"], "rxcui": ["810071", "810077"], "spl_set_id": ["dc532c6c-ff0d-488a-8a92-b1b0f37c944e"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-034-30)", "package_ndc": "31722-034-30", "marketing_start_date": "20240109"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-034-90)", "package_ndc": "31722-034-90", "marketing_start_date": "20240109"}], "brand_name": "FESOTERODINE FUMARATE", "product_id": "31722-034_2f836bf8-7034-db2e-e063-6394a90a3a3e", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "31722-034", "generic_name": "FESOTERODINE FUMARATE", "labeler_name": "Camber Pharmaceuticals, Inc.", "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": "20240109", "listing_expiration_date": "20261231"}