fesoterodine fumarate

Generic: fesoterodine fumarate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fesoterodine fumarate 4 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-369
Product ID 65162-369_84a0cad7-6b3b-46f3-8797-c0b922026154
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205002
Listing Expiration 2026-12-31
Marketing Start 2023-01-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162369
Hyphenated Format 65162-369

Supplemental Identifiers

RxCUI
810071 810077
UPC
0365162370034 0365162369038
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 ANDA205002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-03)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-09)
source: ndc

Packages (2)

65162-369-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-03) 65162-369-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-09)

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": "84a0cad7-6b3b-46f3-8797-c0b922026154", "openfda": {"upc": ["0365162370034", "0365162369038"], "unii": ["EOS72165S7"], "rxcui": ["810071", "810077"], "spl_set_id": ["1d3fdfcf-7406-4be0-90e9-b10c9257bf69"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-03)", "package_ndc": "65162-369-03", "marketing_start_date": "20230106"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-09)", "package_ndc": "65162-369-09", "marketing_start_date": "20230106"}], "brand_name": "Fesoterodine Fumarate", "product_id": "65162-369_84a0cad7-6b3b-46f3-8797-c0b922026154", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "65162-369", "generic_name": "Fesoterodine Fumarate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fesoterodine Fumarate", "active_ingredients": [{"name": "FESOTERODINE FUMARATE", "strength": "4 mg/1"}], "application_number": "ANDA205002", "marketing_category": "ANDA", "marketing_start_date": "20230106", "listing_expiration_date": "20261231"}