0574-0118 NDC - TROSPIUM CHLORIDE

Drug Information

  • Product NDC: 0574-0118
  • Proprietary Name: Trospium Chloride
  • Non Proprietary Name: Trospium Chloride
  • Active Ingredient(s): 60 mg/1 TROSPIUM CHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE, EXTENDED RELEASE
  • Pharmacy Class(es): Cholinergic Muscarinic Antagonist [EPC]; Cholinergic Muscarinic Antagonists [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Padagis US LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA201291
Marketing Category: ANDA
Start Marketing Date:6/7/2013

Package Information

No. Package Code Package Description Billing Unit
10574-0118-3030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0574-0118-30)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0574-0118The 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 NAMETrospium ChlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXERA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMETrospium ChlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, EXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/7/2013Indicates 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.
MARKETING CATEGORY NAMEANDAThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBERANDA201291The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
LABELER NAMEPadagis US LLCThe translation of the dosage form Code submitted by the firm.
SUBSTANCE NAMETROSPIUM CHLORIDEThe translation of the route code submitted by the firm, indicating route of administration.
ACTIVE NUMERATOR STRENGTH60This is the date that the labeler indicates was the start of its marketing of the drug product.
ACTIVE INGRED UNITmg/1 
PHARM CLASSESCholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] 

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

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