Tacrolimus (Page 12 of 12)

Principal Display Panel

05mg
(click image for full-size original)

Principal Display Panel

1mg
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Principal Display Panel

5mg
(click image for full-size original)

TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-752
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 2208 (100 MPA.S)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
SHELLAC
FERRIC OXIDE RED
DIMETHICONE
HYDRATED SILICA
Product Characteristics
Color yellow (yellow opaque body and yellow oaque cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 05;mg;BP;665
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-752-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206651 03/19/2020
TACROLIMUS tacrolimus capsules capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-753
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 2208 (100 MPA.S)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
SHELLAC
FERRIC OXIDE RED
DIMETHICONE
HYDRATED SILICA
Product Characteristics
Color white (white opaque body and white oaque cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 1;mg;BP;666
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-753-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206651 03/19/2020
TACROLIMUS tacrolimus capsules capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-754
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 2208 (100 MPA.S)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE RED
SHELLAC
DIMETHICONE
HYDRATED SILICA
Product Characteristics
Color red (salmon opaque body and salmon oaque cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 5;mg;BP;667
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-754-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206651 03/19/2020
Labeler — AvKARE (796560394)

Revised: 05/2020 AvKARE

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