FDA.reportPublic FDA data

Trospium Chloride

Product NDC
90096-141
11-digit product format
900960141
Labeler code
90096
Product ID
90096-141_415ee086-d26e-4e82-a350-036f5f879256
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zameer Pharmaceuticals LLC
Application
ANDA215781
Marketing category
ANDA
Marketing start
2022-12-03
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90096-141-602024-02-15C16284748780-11030e365-0fa3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TROSPIUM CHLORIDE TABLETS safely and effectively. See full prescribing information for TROSPIUM CHLORIDE TABLETS. TROSPIUM CHLORIDE tablets, for oral use Initial U.S. Approval: 2004
90096-141-602024-01-30C16284748780-11030e365-0fa3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TROSPIUM CHLORIDE TABLETS safely and effectively. See full prescribing information for TROSPIUM CHLORIDE TABLETS. TROSPIUM CHLORIDE tablets, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90096-141-60Trospium Chloride60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
90096-141-60EA - Each90096-141688ab8a1-62c2-4d78-88c9-5aa58d55460412024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90096-141TROSPIUM CHLORIDE TABLET, FILM COATED [ZAMEER PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20241224_048b4bc7-c77e-40fc-9bfb-bb35c6a3f871.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSN048b4bc7-c77e-40fc-9bfb-bb35c6a3f8713
857560trospium chloride 20 MG Oral TabletSCD048b4bc7-c77e-40fc-9bfb-bb35c6a3f8713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
90096-141-609009601416060 TABLET, FILM COATED in 1 BOTTLE (90096-141-60) 2022-12-030000-00-00NoNoCurrent