MedPath
FDA Product

Ziprasidone hydrochloride

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

Basic Information

Ziprasidone hydrochloride

64679-993

Regulatory Information

64679-993

ANDA090348

C73584

November 26, 2019

USA

These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral useInitial U.S. Approval: 2001

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

Wockhardt USA LLC.

170508365

Active Ingredients

ZIPRASIDONE HYDROCHLORIDE

Quantity: 60 mg in 1 1

Code: 216X081ORU

Class Code: ACTIM

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

Active Moieties

ZIPRASIDONE

Code: 6UKA5VEJ6X

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