MedPath
FDA Product

Ziprasidone Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Ziprasidone Hydrochloride

68084-106

Regulatory Information

68084-106

ANDA077561

C73584

September 23, 2022

USA

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

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

929561009

Active Ingredients

ZIPRASIDONE HYDROCHLORIDE

Quantity: 80 mg in 1 1

Code: 216X081ORU

Class Code: ACTIM

Inactive Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

Active Moieties

ZIPRASIDONE

Code: 6UKA5VEJ6X

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