46708-175 NDC - FESOTERODINE FUMARATE

Drug Information

  • Product NDC: 46708-175
  • Proprietary Name: Fesoterodine Fumarate
  • Non Proprietary Name: Fesoterodine Fumarate
  • Active Ingredient(s): 4 mg/1 FESOTERODINE FUMARATE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, EXTENDED RELEASE

Labeler Information

Field Name Field Value
Labeler Name: Alembic Pharmaceuticals Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA204973
Marketing Category: ANDA
Start Marketing Date:1/6/2023

Package Information

No. Package Code Package Description Billing Unit
146708-175-10100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-175-10)
246708-175-3030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-175-30)
346708-175-9090 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-175-90)
446708-175-911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-175-91)

NDC Record

Field Name Field Value Definition
PRODUCT NDC46708-175The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEFesoterodine FumarateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEFesoterodine FumarateThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMETABLET, EXTENDED RELEASEThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
ROUTE NAMEORALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
START MARKETING DATE1/6/2023This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA204973This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEAlembic Pharmaceuticals LimitedThe labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
SUBSTANCE NAMEFESOTERODINE FUMARATEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
ACTIVE NUMERATOR STRENGTH4This is the date that the labeler indicates was the start of its marketing of the drug product.
ACTIVE INGRED UNITmg/1 

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This page was last updated on: 12/6/2025

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