Tacrolimus (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tacrolimus Capsules 0.5 mg

100 Capsules

NDC 67877-278-01

Tacro-05mg-100s
(click image for full-size original)

Tacrolimus Capsules 1 mg

100 Capsules

NDC 67877-279-01

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

Tacrolimus Capsules 5 mg

100 Capsules

NDC 67877-280-01

Tacro-5mg-100s
(click image for full-size original)
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-278
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 (6 MPA.S)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code 0;5mg;Tacro
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-278-33 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (67877-278-33)
2 NDC:67877-278-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203740 11/13/2020
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-279
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 (6 MPA.S)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code 1mg;Tacro
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-279-33 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (67877-279-33)
2 NDC:67877-279-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203740 11/13/2020
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-280
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 (6 MPA.S)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
FERRIC OXIDE RED
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 5mg;Tacro
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-280-33 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (67877-280-33)
2 NDC:67877-280-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203740 11/13/2020
Labeler — Ascend Laboratories, LLC (141250469)
Establishment
Name Address ID/FEI Operations
Alkem Laboratories Limited 677605851 MANUFACTURE (67877-278), MANUFACTURE (67877-279), MANUFACTURE (67877-280)

Revised: 10/2021 Ascend Laboratories, LLC

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