Trospium Chloride

Product NDC
76282-336
11-digit product format
762820336
Labeler code
76282
Product ID
76282-336_0631f266-1c3c-430c-ad8b-66e89161f861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA091688
Marketing category
ANDA
Marketing start
2017-07-11
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

Additional Listing Data#

Finished product
Yes
Brand name base
Trospium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROSPIUM CHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1E6682427E
Rxcui857560

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bfc41181-d174-476d-8a52-4a385ae9213dProduct name120250423
7c473500-2ad1-88f9-e10e-6f8136eda28cProduct name420250226
9151f483-8353-9cd4-427d-86fb1b5ba7eaProduct name420211027

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-336-60Trospium Chloride60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-336-60EA - Each76282-33653ef135a-8eed-4f1e-bb9b-f11f17183eca12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-336TROSPIUM CHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 1 package rows20200923_a4108873-d2d2-4667-b049-02b89b8f2494.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSNa4108873-d2d2-4667-b049-02b89b8f24944
857560trospium chloride 20 MG Oral TabletSCDa4108873-d2d2-4667-b049-02b89b8f24944

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-336-607628203366060 TABLET, FILM COATED in 1 BOTTLE (76282-336-60) 2017-07-110000-00-00NoNoCurrent