FDA.reportPublic FDA data

Trospium Chloride

Product NDC
23155-530
11-digit product format
231550530
Labeler code
23155
Product ID
23155-530_bfcf5966-5504-49de-976a-58d2df90d6e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA204945
Marketing category
ANDA
Marketing start
2016-08-30
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
23155-530-022020-06-02C16284748780-19d75b9d0-ba6a-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
23155-530-052020-06-02C16284748780-19d75b9d0-ba6a-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
23155-530-062020-06-02C16284748780-19d75b9d0-ba6a-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
23155-530-022020-01-31C16284748780-19d75b9d0-ba6a-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
23155-530-052020-01-31C16284748780-19d75b9d0-ba6a-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
23155-530-062020-01-31C16284748780-19d75b9d0-ba6a-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
23155-530-02Trospium Chloride200 in 1 BOTTLETABLET, FILM COATED20012
23155-530-05Trospium Chloride500 in 1 BOTTLETABLET, FILM COATED50012
23155-530-06Trospium Chloride60 in 1 BOTTLETABLET, FILM COATED6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-530-05EA - Each23155-530abd0e481-2d5e-4dfb-adad-573d493e0d2412017-06-15
23155-530-06EA - Each23155-5307a57cd2a-abca-4f0c-b099-f11e8b30e56e12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-530TROSPIUM CHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 3 package rows20230822_570c3ae7-8011-4944-8935-57d0a66102aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSN570c3ae7-8011-4944-8935-57d0a66102aa12
857560trospium chloride 20 MG Oral TabletSCD570c3ae7-8011-4944-8935-57d0a66102aa12
857560trospium chloride 20 MG Oral TabletPSN35ae4d64-4625-4fdd-a2d4-e20b87c568766
857560trospium chloride 20 MG Oral TabletSCD35ae4d64-4625-4fdd-a2d4-e20b87c568766
857560trospium chloride 20 MG Oral TabletPSN48d1b484-ee0a-4d66-9b45-4ba34e65ed134
857560trospium chloride 20 MG Oral TabletSCD48d1b484-ee0a-4d66-9b45-4ba34e65ed134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-530-0223155053002200 TABLET, FILM COATED in 1 BOTTLE (23155-530-02) 2016-08-300000-00-00NoNoCurrent
23155-530-0523155053005500 TABLET, FILM COATED in 1 BOTTLE (23155-530-05) 2016-08-300000-00-00NoNoCurrent
23155-530-062315505300660 TABLET, FILM COATED in 1 BOTTLE (23155-530-06) 2016-08-300000-00-00NoNoCurrent