FDA.reportPublic FDA data

Trospium Chloride

Product NDC
0591-3636
11-digit product format
005913636
Labeler code
0591
Product ID
0591-3636_d9bd46c2-65b5-495b-acae-fcea5f775787
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA091289
Marketing category
ANDA
Marketing start
2012-10-12
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
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 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
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
0591-3636-30Trospium Chloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3636-30EA - Each0591-3636372bb3f2-a5bb-4777-ae79-7028091f4cf112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TROSPIUM CHLORIDEACTIVE INGREDIENT1E6682427ETROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
TROSPIUMACTIVE MOIETYT4Y8ORK057TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
GELATININACTIVE INGREDIENT2G86QN327LTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)INACTIVE INGREDIENT99Q3C7L77TTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
SHELLACINACTIVE INGREDIENT46N107B71OTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
SUCROSEINACTIVE INGREDIENTC151H8M554TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
TALCINACTIVE INGREDIENT7SEV7J4R1UTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]16
TROSPIUM CHLORIDEACTIVE INGREDIENT1E6682427ETROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TROSPIUMACTIVE MOIETYT4Y8ORK057TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)INACTIVE INGREDIENT99Q3C7L77TTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3636TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18Current NDC, Legacy NDC, 1 package rows20181129_8b8d434c-daa2-4bf2-bde6-3e59f81bd88b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSN8b8d434c-daa2-4bf2-bde6-3e59f81bd88b20
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCD8b8d434c-daa2-4bf2-bde6-3e59f81bd88b20
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSY8b8d434c-daa2-4bf2-bde6-3e59f81bd88b20
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSN8e5e2b3a-467b-4312-9778-8ff2ce9388385
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCD8e5e2b3a-467b-4312-9778-8ff2ce9388385
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSY8e5e2b3a-467b-4312-9778-8ff2ce9388385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3636-0500591363605500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-05) 2012-10-120000-00-00NoNoCurrent
0591-3636-300059136363030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-30) 2012-10-120000-00-00NoNoCurrent
0591-3636-600059136366060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-60) 2012-10-120000-00-00NoNoCurrent