Tacrolimus (Page 17 of 17)

PRINCIPAL DISPLAY PANEL Tacrolimus Capsules USP 0.5 mg-100 Capsules-Label

0.5 mg 100 CAPSULES
(click image for full-size original)

Tacrolimus Capsules USP 1 mg-100 Capsules-Label

1 mg 100 CAPSULES
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Tacrolimus Capsules USP 5 mg-100 Capsules-Label

5 mg 100 CAPSULES
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TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-041
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
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
SODIUM LAURYL SULFATE
Product Characteristics
Color yellow (LIGHT YELLOW) Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code TCR;05
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-041-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091195 09/30/2011
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-042
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
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
GELATIN
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color white (WHITE) Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code TCR;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-042-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091195 09/30/2011
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-043
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
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE RED
SODIUM LAURYL SULFATE
Product Characteristics
Color pink (PINK) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code TCR;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-043-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091195 09/30/2011
Labeler — Accord Healthcare Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 manufacture (16729-041), manufacture (16729-042), manufacture (16729-043), analysis (16729-041), analysis (16729-042), analysis (16729-043)

Revised: 09/2020 Accord Healthcare Inc.

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