FDA.reportPublic FDA data

TROSPIUM CHLORIDE

Product NDC
72162-1108
11-digit product format
721621108
Labeler code
72162
Product ID
72162-1108_04e185b1-c67b-4288-ae2f-ff02b29c82fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TROSPIUM CHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091573
Marketing category
ANDA
Marketing start
2010-11-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TROSPIUM CHLORIDE
Listing expiration
2027-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9151f483-8353-9cd4-427d-86fb1b5ba7eaProduct name420211027
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1108-2TROSPIUM CHLORIDE60 in 1 BOTTLETABLET, FILM COATED60102
72162-1108-6TROSPIUM CHLORIDE60 in 1 BOTTLETABLET, FILM COATED60102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1108-6EA - Each72162-1108846c354a-1687-4768-959f-a55be384588d12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1108TROSPIUM CHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20241101_095f54ba-4d43-4266-8942-eede6678ee3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSN095f54ba-4d43-4266-8942-eede6678ee3b102
857560trospium chloride 20 MG Oral TabletSCD095f54ba-4d43-4266-8942-eede6678ee3b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1108-27216211080260 TABLET, FILM COATED in 1 BOTTLE (72162-1108-2) 2023-10-09NoNoHistorical
72162-1108-67216211080660 TABLET, FILM COATED in 1 BOTTLE (72162-1108-6) 2023-10-09NoNoHistorical