Prograf: Package Insert and Label Information (Page 8 of 8)

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets or capsules. 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:

Count1mg
6043353-178-53
9043353-178-60
18043353-178-80
900043353-178-09

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
20140520SC

PRINCIPAL DISPLAY PANEL — 1mg

NDC 43353-178 — Tacrolimus (Prograf®) 1mg — Rx Only

Bottle Label 1mg
(click image for full-size original)

PROGRAF tacrolimus capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-178(NDC:0469-0617)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 1 mg
Product Characteristics
Color WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 11mm
Flavor Imprint Code f;617;1;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-178-53 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
2 NDC:43353-178-60 90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
3 NDC:43353-178-80 180 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
4 NDC:43353-178-09 9000 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050708 04/08/1994
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 Repack (43353-178)

Revised: 05/2014 Aphena Pharma Solutions — Tennessee, LLC

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