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 use Initial U.S. Approval: 2001
Approved
Approval ID
c9f8f635-cf3f-4c42-8bd1-45bbe19bf97e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
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 Code70518-0787
Application NumberANDA204375
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ziprasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (13)
ZIPRASIDONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 216X081ORU
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
AMMONIUM CHLORIDEInactive
Code: 01Q9PC255D
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT