NDC Code(s) : 52125-222-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OlanzapineOlanzapine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-222(NDC:62756-552)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE(UNII: N7U69T4SZR)
(OLANZAPINE - UNII:N7U69T4SZR) 		OLANZAPINE5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code 552
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-222-0230 in 1 BLISTER PACK Type 0: Not a Combination Product09/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091038 09/12/2012

PRINCIPAL DISPLAY PANEL

DRUG: Olanzapine

GENERIC: Olanzapine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-222-02

COLOR: yellow

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: 552

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • OLANZAPINE 5mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • CROSPOVIDONE
  • SILICON DIOXIDE

/xml/034ecaea-ccd2-44b4-a453-1e2e37872d70/Remedy_Label.jpg