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GEODON

These highlights do not include all the information needed to use GEODON safely and effectively. See full prescribing information for GEODON. GEODON (ziprasidone HCl) capsulesGEODON (ziprasidone mesylate) injection for intramuscular useInitial U.S. Approval: 2001

Approved
Approval ID

819997d8-e091-4081-85e1-bf50d39837ee

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 9, 2010

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

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 Code16590-895
Application NumberNDA020825
Product Classification
M
Marketing Category
C73594
G
Generic Name
ZIPRASIDONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2010
FDA Product Classification

INGREDIENTS (3)

ZIPRASIDONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 216X081ORU
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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GEODON - FDA Drug Approval Details