Trospium Chloride

Product NDC
71610-812
11-digit product format
716100812
Labeler code
71610
Product ID
71610-812_1523cfdd-99a0-6b9e-e063-6394a90afd3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204945
Marketing category
ANDA
Marketing start
2015-11-16
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9151f483-8353-9cd4-427d-86fb1b5ba7eaProduct name420211027

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-812-87Trospium Chloride2400 in 1 BOTTLETABLET, FILM COATED24001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-812-87EA - Each71610-8125c990e4e-2bf4-4374-9c6c-c8e3d81f784012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-812TROSPIUM CHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 1 package rows20240405_1523cb4c-3a52-6c18-e063-6394a90a396f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSN1523cb4c-3a52-6c18-e063-6394a90a396f1
857560trospium chloride 20 MG Oral TabletSCD1523cb4c-3a52-6c18-e063-6394a90a396f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-812-87716100812872400 TABLET, FILM COATED in 1 BOTTLE (71610-812-87) 2024-03-28NoNoCurrent