FDA.reportPublic FDA data

Trospium Chloride

Product NDC
33342-554
11-digit product format
333420554
Labeler code
33342
Product ID
33342-554_4d3cbe46-addd-4a3e-850d-ce502fd5cd26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA206472
Marketing category
ANDA
Marketing start
2024-06-18
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
33342-554-09Trospium Chloride60 in 1 BOTTLETABLET602
33342-554-39Trospium Chloride15 in 1 BLISTER PACKTABLET152
33342-554-39Trospium Chloride6 in 1 CARTONTABLET62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-554-09EA - Each33342-55499f0cc33-2ef3-472a-8eb6-bbc24c7b228c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-554TROSPIUM CHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, 3 package rows20240906_fcb13b21-e4a2-461b-b3cb-0daedc722050.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSNfcb13b21-e4a2-461b-b3cb-0daedc7220502
857560trospium chloride 20 MG Oral TabletSCDfcb13b21-e4a2-461b-b3cb-0daedc7220502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-554-093334205540960 TABLET in 1 BOTTLE (33342-554-09) 60 tablet2024-06-18NoNoCurrent
33342-554-39333420554396 BLISTER PACK in 1 CARTON (33342-554-39) / 15 TABLET in 1 BLISTER PACK6 blister pack2024-06-18NoNoCurrent