Trospium Chloride

Product NDC
71610-812
11-digit product format
716100812
Labeler code
71610
Product ID
71610-812_1523cfdd-99a0-6b9e-e063-6394a90afd3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204945
Marketing category
ANDA
Marketing start
2015-11-16
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-812-87716100812872400 TABLET, FILM COATED in 1 BOTTLE (71610-812-87) 2024-03-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Trospium ChlorideAphena Pharma Solutions - Tennessee, LLC2024-04-02HUMAN PRESCRIPTION DRUG LABEL1