LANOXIN (Page 9 of 9)

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:

Count0.125 mg
9071610-019-60

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
20171208DKJ

PRINCIPAL DISPLAY PANEL — 0.125mg

NDC 71610-019 Digoxin (Lanoxin) 0.125mg — Rx Only

Bottle Label 0.125mg
(click image for full-size original)

LANOXIN digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-019(NDC:59212-242)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 0.125 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code LANOXIN;Y3B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-019-60 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/30/2012
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-019)

Revised: 05/2019 Aphena Pharma Solutions — Tennessee, LLC

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