Tacrolimus: Package Insert and Label Information (Page 11 of 11)

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:

Count1 mg
900043353-317-09

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
20171025DKJ

PRINCIPAL DISPLAY PANEL — 1mg

NDC 43353-317 Tacrolimus 1mg — Rx OnlyBottle Label 1mg

TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-317(NDC:60429-378)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 1 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
FERROSOFERRIC OXIDE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
GELATIN
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 1
FD&C RED NO. 3
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color GRAY (gray opaque) , BLUE (light blue opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;2046
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-317-09 9000 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090596 11/18/2015
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (43353-317)

Revised: 05/2017 Aphena Pharma Solutions — Tennessee, LLC

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