Cialis: 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. 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:

Count20 mg
243353-857-02
443353-857-04
643353-857-06
1243353-857-12

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
20171212DKJ

PRINCIPAL DISPLAY PANEL — 20mg

NDC 43353-857 Tadalafil (Cialis) 20mg — Rx OnlyBottle Label 20mg

CIALIS tadalafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-857(NDC:0002-4464)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tadalafil (Tadalafil) Tadalafil 20 mg
Inactive Ingredients
Ingredient Name Strength
Hydroxypropyl cellulose, Unspecified
Hypromellose, Unspecified
FERRIC OXIDE YELLOW
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Sodium lauryl sulfate
Talc
Titanium dioxide
Croscarmellose sodium
Triacetin
Product Characteristics
Color yellow Score no score
Shape OVAL (almond) Size 12mm
Flavor Imprint Code C;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-857-02 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:43353-857-04 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:43353-857-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:43353-857-12 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021368 11/26/2003
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (43353-857)

Revised: 12/2019 Aphena Pharma Solutions — Tennessee, LLC

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