Tacrolimus: Package Insert and Label Information (Page 10 of 10)

0.5 mg 100s Bottle Label

0.5 mg 100s Bottle Label
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0.5 mg 100s Carton Label

0.5 mg 100s Carton Label
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1 mg 100s Bottle Label

1 mg 100s Bottle Label
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1 mg 100s Carton Label

1 mg 100s Carton Label
(click image for full-size original)

5 mg 100s Bottle Label

5 mg 100s Bottle Label
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5 mg 100s Carton Label

5 mg 100s Carton Label
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TACROLIMUS tacrolimus capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-380
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 5mm
Flavor Imprint Code PBT;0;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62175-380-37 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090802 07/30/2015
TACROLIMUS tacrolimus capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-381
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
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 5mm
Flavor Imprint Code PBT;1;0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62175-381-37 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090802 07/30/2015
TACROLIMUS tacrolimus capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-382
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 4mm
Flavor Imprint Code PBT;5;0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62175-382-37 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090802 07/30/2015
Labeler — Kremers Urban Pharmaceuticals Inc. (006422406)
Registrant — Panacea Biotec Ltd (650090566)
Establishment
Name Address ID/FEI Operations
Panacea Biotec Ltd. 677605923 manufacture (62175-380), manufacture (62175-381), manufacture (62175-382)

Revised: 07/2015 Kremers Urban Pharmaceuticals Inc.

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