TROSPIUM CHLORIDE

Product NDC
71335-2961
11-digit product format
713352961
Labeler code
71335
Product ID
71335-2961_3d8d7aaf-991d-4a8d-925f-41f361c79bf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TROSPIUM CHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091573
Marketing category
ANDA
Marketing start
2010-11-17
Substance
TROSPIUM CHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
71335-2961_3d8d7aaf-991d-4a8d-925f-41f361c79bf6
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
TROSPIUM CHLORIDE
Generic name
TROSPIUM CHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Marketing start
2010-11-17
Marketing category
ANDA
Application number
ANDA091573
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC]; Cholinergic Muscarinic Antagonists [MoA]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
TROSPIUM CHLORIDE20 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii1E6682427E
Rxcui857560
Spl Set Id832d1e92-1024-495a-bb7f-590412aae699
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
1E6682427ETROSPIUM CHLORIDE10405-02-4TROSPIUM CHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2961-17133529610160 TABLET, FILM COATED in 1 BOTTLE (71335-2961-1) 2025-10-21NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TROSPIUM CHLORIDEBryant Ranch Prepack2025-10-21HUMAN PRESCRIPTION DRUG LABEL100