FDA.reportPublic FDA data

Trospium Chloride

Product NDC
0574-0118
11-digit product format
005740118
Labeler code
0574
Product ID
0574-0118_d3a1d06a-74e4-40db-890f-046078da9ad2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Padagis US LLC
Application
ANDA201291
Marketing category
ANDA
Marketing start
2013-06-07
Substance
TROSPIUM CHLORIDE
Active strength
60 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
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROSPIUM CHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1E6682427E
Rxcui857564

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
0574-0118-30Trospium ChlorideER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0118-30EA - Each0574-01181db7152b-3735-4fc9-8eed-ca1461288fdc12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Trospium ChlorideACTIVE INGREDIENT1E6682427ETROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
TrospiumACTIVE MOIETYT4Y8ORK057TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
gelatinINACTIVE INGREDIENT2G86QN327LTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
methacrylic acid - ethyl acrylate copolymer (1:1) type aINACTIVE INGREDIENTNX76LV5T8JTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
povidonesINACTIVE INGREDIENTFZ989GH94ETROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
shellacINACTIVE INGREDIENT46N107B71OTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
talcINACTIVE INGREDIENT7SEV7J4R1UTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-0118TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADAGIS US LLC]6Current NDC, Legacy NDC, 1 package rows20240614_4574f905-a8c5-4732-b934-d1c7f9e708c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSN2f431dd1-e130-45e5-a796-1662f498585e105
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCD2f431dd1-e130-45e5-a796-1662f498585e105
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSY2f431dd1-e130-45e5-a796-1662f498585e105
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSNdfc1af0b-b0e7-43fd-8da0-65281963bc3e102
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCDdfc1af0b-b0e7-43fd-8da0-65281963bc3e102
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSYdfc1af0b-b0e7-43fd-8da0-65281963bc3e102
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSNc0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e1100
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCDc0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e1100
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSYc0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e1100
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSN4574f905-a8c5-4732-b934-d1c7f9e708c96
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCD4574f905-a8c5-4732-b934-d1c7f9e708c96
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSY4574f905-a8c5-4732-b934-d1c7f9e708c96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0574-0118-300057401183030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0574-0118-30) 2013-06-070000-00-00NoNoCurrent