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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

a3aa96bb-2cc1-4316-b94c-61593e927505

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 28, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-061
Application NumberNDA020825
Product Classification
M
Marketing Category
C73594
G
Generic Name
ziprasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification

INGREDIENTS (3)

ziprasidone hydrochlorideActive
Quantity: 40 mg in 1 1
Code: 216X081ORU
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT

ziprasidone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-060
Application NumberNDA020825
Product Classification
M
Marketing Category
C73594
G
Generic Name
ziprasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification

INGREDIENTS (3)

ziprasidone hydrochlorideActive
Quantity: 20 mg in 1 1
Code: 216X081ORU
Classification: ACTIM
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT

ziprasidone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-063
Application NumberNDA020825
Product Classification
M
Marketing Category
C73594
G
Generic Name
ziprasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification

INGREDIENTS (3)

lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ziprasidone hydrochlorideActive
Quantity: 80 mg in 1 1
Code: 216X081ORU
Classification: ACTIM

ziprasidone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-062
Application NumberNDA020825
Product Classification
M
Marketing Category
C73594
G
Generic Name
ziprasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification

INGREDIENTS (3)

magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ziprasidone hydrochlorideActive
Quantity: 60 mg in 1 1
Code: 216X081ORU
Classification: ACTIM
lactoseInactive
Code: J2B2A4N98G
Classification: IACT

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Geodon - FDA Drug Approval Details