fesoterodine fumarate

Generic: fesoterodine fumarate

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fesoterodine fumarate 8 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-176
Product ID 46708-176_571147f2-e182-44b5-9d0b-ecfc3265cc2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204973
Listing Expiration 2026-12-31
Marketing Start 2023-01-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708176
Hyphenated Format 46708-176

Supplemental Identifiers

RxCUI
810071 810077
UPC
0346708175306
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 ANDA204973 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-176-10)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-90)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-91)
source: ndc

Packages (4)

46708-176-10 100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-176-10) 46708-176-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-30) 46708-176-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-90) 46708-176-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-91)

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": "571147f2-e182-44b5-9d0b-ecfc3265cc2d", "openfda": {"upc": ["0346708175306"], "unii": ["EOS72165S7"], "rxcui": ["810071", "810077"], "spl_set_id": ["571147f2-e182-44b5-9d0b-ecfc3265cc2d"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-176-10)", "package_ndc": "46708-176-10", "marketing_start_date": "20230106"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-30)", "package_ndc": "46708-176-30", "marketing_start_date": "20230106"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-90)", "package_ndc": "46708-176-90", "marketing_start_date": "20230106"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-91)", "package_ndc": "46708-176-91", "marketing_start_date": "20230106"}], "brand_name": "Fesoterodine Fumarate", "product_id": "46708-176_571147f2-e182-44b5-9d0b-ecfc3265cc2d", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "46708-176", "generic_name": "Fesoterodine Fumarate", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fesoterodine Fumarate", "active_ingredients": [{"name": "FESOTERODINE FUMARATE", "strength": "8 mg/1"}], "application_number": "ANDA204973", "marketing_category": "ANDA", "marketing_start_date": "20230106", "listing_expiration_date": "20261231"}