Prescription Drug Information: Olanzapine (Page 10 of 10)

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count15 mg
3071610-419-30

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20200505JH

PRINCIPAL DISPLAY PANEL — 15 mg

NDC 71610-419 — Olanzapine, USP 15 mg Tablets — Rx Only

Bottle Label 15 mg
(click image for full-size original)

OLANZAPINE olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-419(NDC:60505-3114)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Olanzapine (Olanzapine) Olanzapine 15 mg
Inactive Ingredients
Ingredient Name Strength
Lactose Monohydrate
Cellulose, Microcrystalline
Starch, Corn
Hypromellose 2910 (6 Mpa.S)
Magnesium Stearate
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Polyethylene Glycol 1000
Titanium Dioxide
Fd&C Blue No. 2
Product Characteristics
Color BLUE (light blue) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code APO;OLA;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-419-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090798 04/23/2012
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-419)

Revised: 05/2020 Aphena Pharma Solutions — Tennessee, LLC

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