Tacrolimus: Package Insert and Label Information (Page 11 of 11)

PRINCIPAL DISPLAY PANEL – 0.5 mg

NDC 60429-377-01

Tacrolimus
Capsules, USP
0.5 mg

Rx only 100 Capsules

Each capsule contains:
Tacrolimus, USP 0.5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying prescribing information.

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PRINCIPAL DISPLAY PANEL – 1 mg

NDC 60429-378-01

Tacrolimus
Capsules, USP
1 mg

Rx only 100 Capsules

Each capsule contains:
Tacrolimus, USP 1 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying prescribing information.

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(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 5 mg

NDC 60429-379-01

Tacrolimus
Capsules, USP
5 mg

Rx only 100 Capsules

Each capsule contains:
Tacrolimus, USP 5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying prescribing information.

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TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-378(NDC:0378-2046)
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
FERROSOFERRIC OXIDE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 1
FD&C RED NO. 3
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color blue (light blue opaque) , gray (gray opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;2046
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-378-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090596 09/17/2010
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-377(NDC:0378-2045)
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
FERROSOFERRIC OXIDE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C RED NO. 40
FD&C BLUE NO. 1
FD&C BLUE NO. 2
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color orange (light orange opaque) , gray (gray opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;2045
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-377-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090596 09/17/2010
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-379(NDC:0378-2047)
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
FERROSOFERRIC OXIDE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
D&C RED NO. 33
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color red (rubine red opaque) , gray (gray opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;2047
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-379-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090596 09/17/2010
Labeler — Golden State Medical Supply (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply 603184490 relabel (60429-377), repack (60429-377), relabel (60429-378), repack (60429-378), relabel (60429-379), repack (60429-379)

Revised: 09/2020 Golden State Medical Supply

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