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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE(UNII: 216X081ORU)
(ZIPRASIDONE - UNII:6UKA5VEJ6X) 		ZIPRASIDONE20 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-083-0230 in 1 BLISTER PACK Type 0: Not a Combination Product31/10/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077562 10/31/2014

PRINCIPAL DISPLAY PANEL

DRUG: ziprasidone hydrochloride

GENERIC: ziprasidone hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 61786-083-02

COLOR: yellow

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: SZ;656

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ZIPRASIDONE HYDROCHLORIDE 20mg in 1

INACTIVE INGREDIENT(S):

  • CALCIUM SILICATE
  • FERROSOFERRIC OXIDE
  • POTASSIUM HYDROXIDE
  • TITANIUM DIOXIDE
  • AMMONIA
  • PROPYLENE GLYCOL
  • SHELLAC
  • SODIUM LAURYL SULFATE
  • ANHYDROUS LACTOSE
  • CARBOXYMETHYLCELLULOSE
  • CITRIC ACID MONOHYDRATE
  • MAGNESIUM STEARATE
  • FD&C BLUE NO. 2
  • GELATIN
  • FERRIC OXIDE YELLOW
  • STARCH, CORN

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