Olanzapine (Page 14 of 14)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Olanzapine Tablets, USP 5mg
(click image for full-size original)
Olanzapine Tablets, USP 5mg
OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7161(NDC:33342-068)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
HYDROXYPROPYL CELLULOSE (1200000 MW)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code CL40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7161-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68788-7161-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68788-7161-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202862 06/05/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7161)

Revised: 06/2018 Preferred Pharmaceuticals Inc.

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