ziprasidone hydrochloride
These highlights do not include all the information needed to use ziprasidone hydrochloride capsules safely and effectively. See full prescribing information for ziprasidone hydrochloride capsules. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001
Approved
Approval ID
5752ef72-c515-4ead-a359-69d4761ad7f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2013
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 2
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 Code64725-2168
Application NumberANDA077562
Product Classification
M
Marketing Category
C73584
G
Generic Name
ziprasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2012
FDA Product Classification
INGREDIENTS (17)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ZIPRASIDONE HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: 216X081ORU
Classification: ACTIM
CALCIUM SILICATEInactive
Code: S4255P4G5M
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
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
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
ziprasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-2164
Application NumberANDA077562
Product Classification
M
Marketing Category
C73584
G
Generic Name
ziprasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2012
FDA Product Classification
INGREDIENTS (17)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ZIPRASIDONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 216X081ORU
Classification: ACTIM
CALCIUM SILICATEInactive
Code: S4255P4G5M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT