TROSPIUM CHLORIDE

Product NDC
72789-348
11-digit product format
727890348
Labeler code
72789
Product ID
72789-348_40bb63a7-468a-a247-e063-6394a90acced
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TROSPIUM CHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-348-607278903486060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-348-60) 2023-08-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TROSPIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.2025-10-09HUMAN PRESCRIPTION DRUG LABEL13
TROSPIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.2024-07-31HUMAN PRESCRIPTION DRUG LABEL12