FDA.reportPublic FDA data

Trospium Chloride

Product NDC
69150-258
11-digit product format
691500258
Labeler code
69150
Product ID
69150-258_62d7ea83-76ae-4200-bb57-ff384c907536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET
Route
ORAL
Labeler
BIOMES PHARMACEUTICALS LLC
Application
ANDA091575
Marketing category
ANDA
Marketing start
2010-08-13
Marketing end
0000-00-00
Substance
TROSPIUM CHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69150-258IInactivated by FDA2026-08-03
excluded packagepackage69150-25869150-258-06IInactivated by FDA2026-08-03

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bfc41181-d174-476d-8a52-4a385ae9213dProduct name120250423
7c473500-2ad1-88f9-e10e-6f8136eda28cProduct name420250226
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9151f483-8353-9cd4-427d-86fb1b5ba7eaProduct name420211027

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69150-258-062020-01-31C16284748780-19d75b9d0-b8b1-f424-e053-dadaa90a57ceThese 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 USP, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69150-258-06Trospium Chloride60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69150-258TROSPIUM CHLORIDE TABLET [BIOMES PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20171026_11367381-62c6-4a8c-84c7-031dd75372e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSN11367381-62c6-4a8c-84c7-031dd75372e21
857560trospium chloride 20 MG Oral TabletSCD11367381-62c6-4a8c-84c7-031dd75372e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69150-258-066915002580660 in 1 BOTTLEHistorical