TROSPIUM CHLORIDE

Product NDC
63629-8457
11-digit product format
636298457
Labeler code
63629
Product ID
63629-8457_33088c98-8ffc-410a-9135-7cc6b3d4843b
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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
63629-8457-1TROSPIUM CHLORIDE60 in 1 BOTTLETABLET, FILM COATED60103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8457-1EA - Each63629-8457adce4ffd-d234-4823-964e-e740e9b90a4e12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8457TROSPIUM CHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20231108_871d70aa-4a7d-44dd-933c-969164b75942.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSN871d70aa-4a7d-44dd-933c-969164b75942103
857560trospium chloride 20 MG Oral TabletSCD871d70aa-4a7d-44dd-933c-969164b75942103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8457-16362984570160 TABLET, FILM COATED in 1 BOTTLE (63629-8457-1) 2022-02-090000-00-00NoNoCurrent