Trospium Chloride

Product NDC
69097-912
11-digit product format
690970912
Labeler code
69097
Product ID
69097-912_9058b0be-0e24-418e-9be7-597c00fe8b70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CIPLA USA INC.,
Application
ANDA091688
Marketing category
ANDA
Marketing start
2016-09-23
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-912-02Trospium Chloride30 in 1 BOTTLETABLET, FILM COATED303
69097-912-03Trospium Chloride60 in 1 BOTTLETABLET, FILM COATED603
69097-912-15Trospium Chloride1000 in 1 BOTTLETABLET, FILM COATED10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-912-03EA - Each69097-912d9d0e4d5-b60c-40c0-a1c3-0867ae53e0fb12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-912TROSPIUM CHLORIDE TABLET, FILM COATED [CIPLA USA INC.,]3Current NDC, Legacy NDC, 3 package rows20200905_6a711666-9e80-4728-b745-e7dc86f57510.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSN6a711666-9e80-4728-b745-e7dc86f575103
857560trospium chloride 20 MG Oral TabletSCD6a711666-9e80-4728-b745-e7dc86f575103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-912-026909709120230 TABLET, FILM COATED in 1 BOTTLE (69097-912-02) 2016-09-230000-00-00NoNoCurrent
69097-912-036909709120360 TABLET, FILM COATED in 1 BOTTLE (69097-912-03) 2016-09-230000-00-00NoNoCurrent
69097-912-15690970912151000 TABLET, FILM COATED in 1 BOTTLE (69097-912-15) 2016-09-230000-00-00NoNoCurrent