thiothixene

Thiothixene Capsules, USP (1 mg, 2 mg, 5 mg and 10 mg) Rx Only

Approved

Approval ID

81c40311-7dc4-4332-8920-a39a8466aea6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 28, 2023

Manufacturers

FDA

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

thiothixene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60219-1676

Application NumberANDA215456

Product Classification

Marketing Category

C73584

Generic Name

thiothixene

Product Specifications

Route of AdministrationORAL

Effective DateDecember 28, 2023

FDA Product Classification

INGREDIENTS (17)

THIOTHIXENEActive

Quantity: 10 mg in 1 1

Code: 7318FJ13YJ

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

thiothixene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60219-1673

Application NumberANDA215456

Product Classification

Marketing Category

C73584

Generic Name

thiothixene

Product Specifications

Route of AdministrationORAL

Effective DateDecember 28, 2023

FDA Product Classification

INGREDIENTS (20)

THIOTHIXENEActive

Quantity: 1 mg in 1 1

Code: 7318FJ13YJ

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

thiothixene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60219-1675

Application NumberANDA215456

Product Classification

Marketing Category

C73584

Generic Name

thiothixene

Product Specifications

Route of AdministrationORAL

Effective DateDecember 28, 2023

FDA Product Classification

INGREDIENTS (17)

THIOTHIXENEActive

Quantity: 5 mg in 1 1

Code: 7318FJ13YJ

Classification: ACTIB

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

thiothixene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code60219-1674

Application NumberANDA215456

Product Classification

Marketing Category

C73584

Generic Name

thiothixene

Product Specifications

Route of AdministrationORAL

Effective DateDecember 28, 2023

FDA Product Classification

INGREDIENTS (18)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

THIOTHIXENEActive

Quantity: 2 mg in 1 1

Code: 7318FJ13YJ

Classification: ACTIB

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

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thiothixene

Products 4

thiothixene

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

thiothixene

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

thiothixene

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

thiothixene

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

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