Tacrolimus (Page 14 of 14)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.5mg -- 100s -- Container Label
(click image for full-size original)

0.5mg — 100s — Container Label

1mg -- 100s -- Container Label
(click image for full-size original)

1mg — 100s — Container Label

5mg -- 100s -- Container Label
(click image for full-size original)

5mg — 100s — Container Label

TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-720
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
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
Product Characteristics
Color RED (red opaque cap and red opaque body) Score no score
Shape CAPSULE (hard gelatin) Size 11mm
Flavor Imprint Code SAL;720
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-720-06 100 CAPSULE in 1 CONTAINER None
2 NDC:64380-720-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (64380-720-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090687 08/13/2014
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-721
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
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN (green opaque cap and green opaque body) Score no score
Shape CAPSULE (hard gelatin) Size 11mm
Flavor Imprint Code SAL;721
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-721-06 100 CAPSULE in 1 CONTAINER None
2 NDC:64380-721-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (64380-721-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090687 08/13/2014
TACROLIMUS tacrolimus capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-722
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
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
CROSCARMELLOSE SODIUM
D&C RED NO. 28
D&C YELLOW NO. 10
Product Characteristics
Color BLUE (teal opaque cap and teal opaque body) Score no score
Shape CAPSULE (hard gelatin) Size 14mm
Flavor Imprint Code SAL;722
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-722-06 100 CAPSULE in 1 CONTAINER None
2 NDC:64380-722-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (64380-722-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090687 08/13/2014
Labeler — Strides Shasun Limited (650738743)
Registrant — Strides Shasun Limited (918513263)
Establishment
Name Address ID/FEI Operations
Strides Shasun Limited 918513263 ANALYSIS (64380-720), ANALYSIS (64380-721), ANALYSIS (64380-722), MANUFACTURE (64380-720), MANUFACTURE (64380-721), MANUFACTURE (64380-722), PACK (64380-720), PACK (64380-721), PACK (64380-722)

Revised: 12/2016 Strides Shasun Limited

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