Olanzapine (Page 14 of 14)

PRINCIPAL DISPLAY PANEL

Olanzapine 7.5mg
(click image for full-size original)

OLANZAPINE
olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-222(NDC:0093-5769)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARRAGEENAN
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (Off-white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code TEVA;5769
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-222-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076000 10/24/2011
Labeler — Rebel Distributors Corp (118802834)
Registrant — PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Operations
PSS World Medical, Inc. 791528623 REPACK (42254-222)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 REPACK (42254-222)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 RELABEL (42254-222), REPACK (42254-222)
Establishment
Name Address ID/FEI Operations
SCRIPT PAK 964420108 RELABEL (42254-222), REPACK (42254-222)
Establishment
Name Address ID/FEI Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK (42254-222)
Establishment
Name Address ID/FEI Operations
Rebel Distirbutors Corp. 118802834 RELABEL (42254-222), REPACK (42254-222)

Revised: 05/2012 Rebel Distributors Corp

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