Ziprasidone
These highlights do not include all the information needed to use Ziprasidone safely and effectively. See full prescribing information for ziprasidone. Ziprasidone HCl capsules Initial U.S. Approval: 2001
Approved
Approval ID
f998bc73-cc9e-47bf-a2c4-1129198905fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 20, 2017
Manufacturers
FDA
Avera McKennan Hospital
DUNS: 068647668
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 Code69189-2003
Application NumberNDA020825
Product Classification
M
Marketing Category
C73605
G
Generic Name
ziprasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 20, 2017
FDA Product Classification
INGREDIENTS (3)
ZIPRASIDONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 216X081ORU
Classification: ACTIM
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT