FDA.reportPublic FDA data

Trospium Chloride

Product NDC
68462-461
11-digit product format
684620461
Labeler code
68462
Product ID
68462-461_44d944da-d624-4016-a3eb-ce810b62fb17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA091575
Marketing category
ANDA
Marketing start
2010-08-13
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091575-001TROSPIUM CHLORIDETROSPIUM CHLORIDE20MGTABLET / ORALABRS2010-08-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A091575-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091575-001TROSPIUM CHLORIDE20MGTABLET / ORALABRS2010-08-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091575-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trospium ChlorideTROSPIUM CHLORIDEGlenmark Pharmaceuticals Inc., USAd5c837a4-d1c6-4615-b7ad-27f3162a03aa2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091575
application number: ANDA091575
ndc (product): 68462-461

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1E6682427EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857560Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d5c837a4-d1c6-4615-b7ad-27f3162a03aaAvailable on FDA.report

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
68462-461-05Trospium Chloride500 in 1 BOTTLETABLET, FILM COATED50018
68462-461-10Trospium Chloride1000 in 1 BOTTLETABLET, FILM COATED100018
68462-461-30Trospium Chloride30 in 1 BOTTLETABLET, FILM COATED3018
68462-461-60Trospium Chloride60 in 1 BOTTLETABLET, FILM COATED6018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-461-10EA - Each68462-461d539919a-5ff8-4e34-8d68-c750c609ad8512016-12-07
68462-461-60EA - Each68462-4613f4511d2-2004-49a5-8b15-377302d3152b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TROSPIUM CHLORIDEACTIVE INGREDIENT1E6682427ETROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
TROSPIUMACTIVE MOIETYT4Y8ORK057TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BTROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WETROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ETROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
SUCROSEINACTIVE INGREDIENTC151H8M554TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
TALCINACTIVE INGREDIENT7SEV7J4R1UTROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-461TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]17Current NDC, Legacy NDC, 4 package rows20231228_d5c837a4-d1c6-4615-b7ad-27f3162a03aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSNd5c837a4-d1c6-4615-b7ad-27f3162a03aa18
857560trospium chloride 20 MG Oral TabletSCDd5c837a4-d1c6-4615-b7ad-27f3162a03aa18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-461-0568462046105500 TABLET, FILM COATED in 1 BOTTLE (68462-461-05) 2010-08-130000-00-00NoNoCurrent
68462-461-10684620461101000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10) 2023-06-30NoNoCurrent
68462-461-306846204613030 TABLET, FILM COATED in 1 BOTTLE (68462-461-30) 2010-08-130000-00-00NoNoCurrent
68462-461-606846204616060 TABLET, FILM COATED in 1 BOTTLE (68462-461-60) 2010-08-130000-00-00NoNoCurrent