ziprasidone hydrochloride

These highlights do not include all the information needed to use ZIPRASIDONE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE CAPSULES. ZIPRASIDONE capsules, for oral useInitial U.S. Approval: 2001

Approved

Approval ID

f3e54e15-945c-4e1e-b992-d01e6872d606

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 19, 2022

Manufacturers

FDA

Sandoz Inc

DUNS: 005387188

Products 4

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

ziprasidone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0781-2168

Application NumberANDA077562

Product Classification

Marketing Category

C73584

Generic Name

ziprasidone hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 27, 2020

FDA Product Classification

INGREDIENTS (17)

ZIPRASIDONE HYDROCHLORIDEActive

Quantity: 80 mg in 1 1

Code: 216X081ORU

Classification: ACTIM

CALCIUM SILICATEInactive

Code: S4255P4G5M

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

CARBOXYMETHYLCELLULOSEInactive

Code: 05JZI7B19X

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ziprasidone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0781-2164

Application NumberANDA077562

Product Classification

Marketing Category

C73584

Generic Name

ziprasidone hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 27, 2020

FDA Product Classification

INGREDIENTS (17)

CALCIUM SILICATEInactive

Code: S4255P4G5M

Classification: IACT

ZIPRASIDONE HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 216X081ORU

Classification: ACTIM

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

CARBOXYMETHYLCELLULOSEInactive

Code: 05JZI7B19X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ziprasidone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0781-2167

Application NumberANDA077562

Product Classification

Marketing Category

C73584

Generic Name

ziprasidone hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 27, 2020

FDA Product Classification

INGREDIENTS (16)

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

CALCIUM SILICATEInactive

Code: S4255P4G5M

Classification: IACT

ZIPRASIDONE HYDROCHLORIDEActive

Quantity: 60 mg in 1 1

Code: 216X081ORU

Classification: ACTIM

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

CARBOXYMETHYLCELLULOSEInactive

Code: 05JZI7B19X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ziprasidone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0781-2166

Application NumberANDA077562

Product Classification

Marketing Category

C73584

Generic Name

ziprasidone hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 27, 2020

FDA Product Classification

INGREDIENTS (14)

ZIPRASIDONE HYDROCHLORIDEActive

Quantity: 40 mg in 1 1

Code: 216X081ORU

Classification: ACTIM

CALCIUM SILICATEInactive

Code: S4255P4G5M

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

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ziprasidone hydrochloride

Products 4

ziprasidone hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

ziprasidone hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

ziprasidone hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

ziprasidone hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

MedPath

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Company

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