Tacrolimus (Page 12 of 12)

Package/Label Display Panel – Carton – 0.5 mg

0.5 mg Tacrolims Capsules Carton
(click image for full-size original)

NDC 68084- 449 -01

Tacrolimus
Capsules, USP

0.5 mg

100 Capsules (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Patient
Information Sheet to each patient.

Each Capsule Contains:
Tacrolimus USP……………………………………………… 0.5 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 55111-525, Dr. Reddy’s Laboratories Limited.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

044901 0244901/1218OS

Package/Label Display Panel – Blister -0.5 mg

0.5 mg Tacrolimus Capsule Blister
(click image for full-size original)

Tacrolimus Capsule, USP

0.5 mg

Package/Label Display Panel – Carton – 1 mg

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

NDC 68084- 450 -01

Tacrolimus
Capsules, USP

1 mg

100 Capsules (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Patient
Information Sheet to each patient.

Each Capsule Contains:
Tacrolimus USP………………………………………………… 1 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 55111-526, Dr. Reddy’s Laboratories Limited.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

045001 0245001/1218OS

Package/Label Display Panel – Blister – 1 mg

1 mg Tacrolimus Capsule Blister
(click image for full-size original)

Tacrolimus Capsule, USP

1 mg

Package/Label Display Panel – Carton – 5 mg

5 mg Tacrolimus Capsules Carton
(click image for full-size original)

NDC 68084- 451 -01

Tacrolimus
Capsules, USP

5 mg

100 Capsules (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Patient
Information Sheet to each patient.

Each Capsule Contains:
Tacrolimus USP………………………………………………… 5 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 55111-527, Dr. Reddy’s Laboratories Limited.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

045101 0245101/1218OS

Package/Label Display Panel – Blister – 5 mg

5 mg Tacrolimus Capsule Blister
(click image for full-size original)

Tacrolimus Capsule, USP

5 mg

TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-449(NDC:55111-525)
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
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color yellow (dark yellow) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 0;5MG;RDY;525
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-449-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-449-11)
1 NDC:68084-449-11 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-449-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090509 07/29/2010
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-450(NDC:55111-526)
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
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 1MG;RDY;526
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-450-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-450-11)
1 NDC:68084-450-11 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-450-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090509 07/30/2010
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-451(NDC:55111-527)
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
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
Product Characteristics
Color red (dark grayish red) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 5MG;RDY;527
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-451-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-451-11)
1 NDC:68084-451-11 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-451-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090509 07/30/2010
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-449), repack (68084-450), repack (68084-451)

Revised: 07/2020 American Health Packaging

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