NDC 61786-083-02
API & Excipient Details

Ziprasidone Hydrochloride marketed by REMEDYREPACK INC. under NDC Code 61786-083-02

NDC Code(s) : 61786-083-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ziprasidone hydrochlorideziprasidone hydrochloride CAPSULE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:61786-083(NDC:0781-2164)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZIPRASIDONE HYDROCHLORIDE(UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)	ZIPRASIDONE	20 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM SILICATE(UNII: S4255P4G5M)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
CARBOXYMETHYLCELLULOSE(UNII: 05JZI7B19X)

Product Characteristics
Color	yellow (opaque yellow cap), blue (opaque blue body)	Score	no score
Shape	CAPSULE	Size	14 mm
Flavor		Imprint Code	SZ;656
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61786-083-02	30 in 1 BLISTER PACK Type 0: Not a Combination Product	31/10/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077562	10/31/2014

PRINCIPAL DISPLAY PANEL