VALSARTAN (Page 7 of 7)

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:

Count320mg
216043353-203-79

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
20160713DH

Package/Label Display Panel

NDC 43353-203-79

VALSARTAN TABLETS, USP

320 mg

PHARMACIST: Dispense with the Patient Information Leaflet.

Rx only 2160 Tablets

320mg
(click image for full-size original)
VALSARTAN
valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-203(NDC:51660-143)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALSARTAN (VALSARTAN) VALSARTAN 320 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOLS
FERRIC OXIDE YELLOW
Product Characteristics
Color brown Score no score
Shape OVAL Size 19mm
Flavor Imprint Code RX126
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-203-79 2160 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077492 07/07/2014
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (43353-203)

Revised: 07/2016 Aphena Pharma Solutions — Tennessee, LLC

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