Tacrolimus (Page 15 of 15)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-685
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
HYPROMELLOSE, UNSPECIFIED
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
FD&C BLUE NO. 1
FD&C RED NO. 40
D&C YELLOW NO. 10
TITANIUM DIOXIDE
SHELLAC
SODIUM HYDROXIDE
POVIDONE, UNSPECIFIED
Product Characteristics
Color YELLOW (light yellow cap) , YELLOW (light yellow body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code G;685
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-685-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206662 11/10/2020
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-686
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
HYPROMELLOSE, UNSPECIFIED
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FD&C RED NO. 40
SHELLAC
SODIUM HYDROXIDE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE (white cap) , WHITE (white body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code G;686
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-686-01 100 CAPSULE in 1 BOTTLE None
2 NDC:68462-686-14 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (68462-686-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206662 11/10/2020
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-687
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
LACTOSE MONOHYDRATE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
FD&C BLUE NO. 1
FD&C RED NO. 40
D&C YELLOW NO. 10
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
Product Characteristics
Color RED (greyish red cap) , RED (greyish red body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code G;687
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-687-01 100 CAPSULE in 1 BOTTLE None
2 NDC:68462-687-14 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (68462-687-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206662 11/10/2020
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 MANUFACTURE (68462-685), MANUFACTURE (68462-686), MANUFACTURE (68462-687), ANALYSIS (68462-685), ANALYSIS (68462-686), ANALYSIS (68462-687)

Revised: 10/2023 Glenmark Pharmaceuticals Inc., USA

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