NDC Code(s) : 64380-720-06, 64380-720-01, 64380-721-06, 64380-721-01, 64380-722-01, 64380-722-06
Packager : Strides Pharma Science Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

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(UNII: WM0HAQ4WNM)
(TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J) 		TACROLIMUS ANHYDROUS0.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color RED (red opaque cap and red opaque body) Score no score
Shape CAPSULE (hard gelatin) Size 11 mm
Flavor Imprint Code SAL;720
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64380-720-06100 in 1 CONTAINER Type 0: Not a Combination Product10/05/2020
2NDC:64380-720-0110 in 1 CARTON 10/05/2020
210 in 1 BLISTER PACK Type 0: Not a Combination Product10/05/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090687 10/05/2020
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(UNII: WM0HAQ4WNM)
(TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J) 		TACROLIMUS ANHYDROUS1 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color GREEN (green opaque cap and green opaque body) Score no score
Shape CAPSULE (hard gelatin) Size 11 mm
Flavor Imprint Code SAL;721
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64380-721-06100 in 1 CONTAINER Type 0: Not a Combination Product13/08/2014
2NDC:64380-721-0110 in 1 CARTON 13/08/2014
210 in 1 BLISTER PACK Type 0: Not a Combination Product13/08/2014
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(UNII: WM0HAQ4WNM)
(TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J) 		TACROLIMUS ANHYDROUS5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C RED NO. 28(UNII: 767IP0Y5NH)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color BLUE (teal opaque cap and teal opaque body) Score no score
Shape CAPSULE (hard gelatin) Size 14 mm
Flavor Imprint Code SAL;722
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64380-722-0110 in 1 CARTON 10/05/2020
110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:64380-722-06100 in 1 CONTAINER Type 0: Not a Combination Product10/05/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090687 10/05/2020

LABELER - Strides Pharma Science Limited(650738743)

REGISTRANT - Strides Pharma Global Pte. Ltd.(659220961)

Establishment
Name Address ID/FEI Business Operations
Strides Pharma Science Limited 918513263 ANALYSIS(64380-720, 64380-721, 64380-722), MANUFACTURE(64380-720, 64380-721, 64380-722), PACK(64380-720, 64380-721, 64380-722)

PRINCIPAL DISPLAY PANEL

0.5 mg - 100s - Container Label0.5 mg - 100s - Container Label0.5 mg - 100s - Container Label