Thiothixene

Approved

Approval ID

9480a406-c85b-ba06-e053-2a95a90a0912

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 24, 2023

Manufacturers

FDA

Golden State Medical Supply, Inc.

DUNS: 603184490

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 Code51407-275

Application NumberANDA211642

Product Classification

Marketing Category

C73584

Generic Name

Thiothixene

Product Specifications

Route of AdministrationORAL

Effective DateAugust 24, 2023

FDA Product Classification

INGREDIENTS (19)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

THIOTHIXENEActive

Quantity: 1 mg in 1 1

Code: 7318FJ13YJ

Classification: ACTIB

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

Thiothixene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51407-278

Application NumberANDA211642

Product Classification

Marketing Category

C73584

Generic Name

Thiothixene

Product Specifications

Route of AdministrationORAL

Effective DateAugust 24, 2023

FDA Product Classification

INGREDIENTS (18)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

THIOTHIXENEActive

Quantity: 10 mg in 1 1

Code: 7318FJ13YJ

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

Thiothixene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51407-276

Application NumberANDA211642

Product Classification

Marketing Category

C73584

Generic Name

Thiothixene

Product Specifications

Route of AdministrationORAL

Effective DateAugust 24, 2023

FDA Product Classification

INGREDIENTS (19)

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

THIOTHIXENEActive

Quantity: 2 mg in 1 1

Code: 7318FJ13YJ

Classification: ACTIB

Thiothixene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51407-277

Application NumberANDA211642

Product Classification

Marketing Category

C73584

Generic Name

Thiothixene

Product Specifications

Route of AdministrationORAL

Effective DateAugust 24, 2023

FDA Product Classification

INGREDIENTS (18)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

THIOTHIXENEActive

Quantity: 5 mg in 1 1

Code: 7318FJ13YJ

Classification: ACTIB

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/8/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Thiothixene Capsules, USP 1 mg 100's counts
51407-275-01OL - Thiothixene Capsules - Novitium - Rev.0823.jpg

Thiothixene Capsules, USP 2 mg 100'scounts
51407-276-01OL - Thiothixene Capsules - Novitium - Rev.0823.jpg
Thiothixene Capsules, USP 5 mg 100'scounts
51407-277-01OL - Thiothixene Capsules - Novitium - Rev.0823.jpg

Thiothixene Capsules, USP 10 mg 100'scounts
51407-278-01OL - Thiothixene Capsules - Novitium - Rev.0823.jpg

DESCRIPTION SECTION

LOINC: 34089-3Updated: 9/8/2020

DESCRIPTION

Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4- methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. It may be represented by the following structural formula

Thio-structure

The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide functional group is bonded to the thioxanthene nucleus.

Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 1 mg empty gelatin capsules contain D&C Red No. 28 and the 2 mg empty gelatin capsules contain D&C Yellow No. 10.

The imprinting ink contains the following: ammonia solution, black iron oxide, potassium hydroxide, propylene glycol and shellac.

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Thiothixene

Products 4

Thiothixene

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Thiothixene

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Thiothixene

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Thiothixene

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DESCRIPTION SECTION

DESCRIPTION

MedPath

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Company

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