Tarka

TARKA®(trandolapril/verapamil hydrochloride ER tablets)

Approved

Approval ID

3b4b1dd5-8a6f-4f0e-a2ea-506c60d6fce9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 13, 2012

Manufacturers

FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 3

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

Trandolapril and Verapamil Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5311

Application NumberNDA020591

Product Classification

Marketing Category

C73594

Generic Name

Trandolapril and Verapamil Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 13, 2012

FDA Product Classification

INGREDIENTS (18)

povidoneInactive

Code: FZ989GH94E

Classification: IACT

trandolaprilActive

Quantity: 2 mg in 1 1

Code: 1T0N3G9CRC

Classification: ACTIB

verapamil hydrochlorideActive

Quantity: 240 mg in 1 1

Code: V3888OEY5R

Classification: ACTIB

DOCUSATE SODIUMInactive

Code: F05Q2T2JA0

Classification: IACT

lactoseInactive

Code: J2B2A4N98G

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

hydroxypropyl celluloseInactive

Code: RFW2ET671P

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

sodium alginateInactive

Code: C269C4G2ZQ

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

sodium stearyl fumarateInactive

Code: 7CV7WJK4UI

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

Trandolapril and Verapamil Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5548

Application NumberNDA020591

Product Classification

Marketing Category

C73594

Generic Name

Trandolapril and Verapamil Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 13, 2012

FDA Product Classification

INGREDIENTS (18)

trandolaprilActive

Quantity: 2 mg in 1 1

Code: 1T0N3G9CRC

Classification: ACTIB

DOCUSATE SODIUMInactive

Code: F05Q2T2JA0

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

verapamil hydrochlorideActive

Quantity: 180 mg in 1 1

Code: V3888OEY5R

Classification: ACTIB

hydroxypropyl celluloseInactive

Code: RFW2ET671P

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

lactoseInactive

Code: J2B2A4N98G

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

povidoneInactive

Code: FZ989GH94E

Classification: IACT

sodium alginateInactive

Code: C269C4G2ZQ

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

sodium stearyl fumarateInactive

Code: 7CV7WJK4UI

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

Trandolapril and Verapamil Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5320

Application NumberNDA020591

Product Classification

Marketing Category

C73594

Generic Name

Trandolapril and Verapamil Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 13, 2012

FDA Product Classification

INGREDIENTS (18)

sodium alginateInactive

Code: C269C4G2ZQ

Classification: IACT

sodium stearyl fumarateInactive

Code: 7CV7WJK4UI

Classification: IACT

verapamil hydrochlorideActive

Quantity: 240 mg in 1 1

Code: V3888OEY5R

Classification: ACTIB

DOCUSATE SODIUMInactive

Code: F05Q2T2JA0

Classification: IACT

trandolaprilActive

Quantity: 4 mg in 1 1

Code: 1T0N3G9CRC

Classification: ACTIB

lactoseInactive

Code: J2B2A4N98G

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

hydroxypropyl celluloseInactive

Code: RFW2ET671P

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

povidoneInactive

Code: FZ989GH94E

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

AI-Powered Research

Premium Access

Tarka

Products 3

Trandolapril and Verapamil Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Trandolapril and Verapamil Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Trandolapril and Verapamil Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

MedPath

Product

Company

Legal