TROSPIUM CHLORIDE

Product NDC
0574-0145
11-digit product format
005740145
Labeler code
0574
Product ID
0574-0145_89cdc3a1-78f6-49df-ae6c-91205463fc63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TROSPIUM CHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Padagis US LLC
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
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
0574-0145-60TROSPIUM CHLORIDE60 in 1 BOTTLETABLET, FILM COATED609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0145-60EA - Each0574-014568ace3dc-65f4-4ce3-83b1-7ac8b02cb91112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TROSPIUM CHLORIDEACTIVE INGREDIENT1E6682427ETROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
TROSPIUMACTIVE MOIETYT4Y8ORK057TROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKTROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PTROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ETROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
TALCINACTIVE INGREDIENT7SEV7J4R1UTROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTROSPIUM CHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-0145TROSPIUM CHLORIDE TABLET, FILM COATED [PADAGIS US LLC]9Current NDC, Legacy NDC, 1 package rows20240517_bb3284ee-3d13-41c7-8e4b-f9b2d44350da.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
857560trospium chloride 20 MG Oral TabletPSN095f54ba-4d43-4266-8942-eede6678ee3b102
857560trospium chloride 20 MG Oral TabletPSN1065cfd9-3d32-466c-8dff-c81eae1a0533102
857560trospium chloride 20 MG Oral TabletSCD095f54ba-4d43-4266-8942-eede6678ee3b102
857560trospium chloride 20 MG Oral TabletSCD1065cfd9-3d32-466c-8dff-c81eae1a0533102
857560trospium chloride 20 MG Oral TabletPSN832d1e92-1024-495a-bb7f-590412aae699100
857560trospium chloride 20 MG Oral TabletSCD832d1e92-1024-495a-bb7f-590412aae699100
857560trospium chloride 20 MG Oral TabletPSN6303cf3c-175c-46ff-9b88-05f6ea7a213513
857560trospium chloride 20 MG Oral TabletSCD6303cf3c-175c-46ff-9b88-05f6ea7a213513
857560trospium chloride 20 MG Oral TabletPSNbb3284ee-3d13-41c7-8e4b-f9b2d44350da9
857560trospium chloride 20 MG Oral TabletSCDbb3284ee-3d13-41c7-8e4b-f9b2d44350da9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0574-0145-600057401456060 TABLET, FILM COATED in 1 BOTTLE (0574-0145-60) 2010-11-170000-00-00NoNoCurrent