Tacrolimus (Page 17 of 17)

PRINCIPAL DISPLAY PANEL – 0.5 mg

NDC 51079-817-20

Tacrolimus
Capsules, USP
0.5 mg

100 Capsules (10 x 10)

Each capsule contains:
Tacrolimus, USP 0.5 mg

Usual Dosage: See accompanying
prescribing information.

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

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-10643 R4

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

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

This container provides light-resistance.

See window for lot number and expiration date.

Tacrolimus 0.5 mg Capsules Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 1 mg

NDC 51079-818-20

Tacrolimus
Capsules, USP
1 mg

100 Capsules (10 x 10)

Each capsule contains:
Tacrolimus, USP 1 mg

Usual Dosage: See accompanying
prescribing information.

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

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-10644 R4

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

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

This container provides light-resistance.

See window for lot number and expiration date.

Tacrolimus 1 mg Capsules Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 5 mg

NDC 51079-028-20

Tacrolimus
Capsules, USP
5 mg

100 Capsules (10 x 10)

Each capsule contains:
Tacrolimus, USP 5 mg

Usual Dosage: See accompanying
prescribing information.

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

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-10645 R4

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

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

This container provides light-resistance.

See window for lot number and expiration date.

Tacrolimus 5 mg Capsules Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-817(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:51079-817-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-817-01)
1 NDC:51079-817-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-817-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090596 11/15/2010
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-818(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:51079-818-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-818-01)
1 NDC:51079-818-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-818-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090596 11/01/2010
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-028(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:51079-028-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-028-01)
1 NDC:51079-028-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-028-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090596 11/01/2010
Labeler — Mylan Institutional Inc. (039615992)

Revised: 01/2020 Mylan Institutional Inc.

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