Tacrolimus (Page 16 of 16)

0.5 mg bottle

BIONPHARMA

NDC 69452- 153 -20

Tacrolimus Capsules USP,

0.5 mg

Rx only

100 Capsules

BIONPHARMA

NDC 69452- 153 -20

Tacrolimus Capsules USP,

0.5 mg

100 Capsules

BIONPHARMA

NDC 69452- 154 -20

Tacrolimus Capsules USP,

1 mg

Rx only

100 Capsules

BIONPHARMA

NDC 69452- 154 -20

Tacrolimus Capsules USP,

1 mg

100 Capsules

BIONPHARMA

NDC 69452- 155 -20

Tacrolimus Capsules USP,

5 mg

Rx only

100 Capsules

BIONPHARMA

NDC 69452 -155- 20

Tacrolimus Capsules USP,

5 mg

100 Capsules

TACROLIMUS tacrolimus capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-153 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 HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) CROSCARMELLOSE SODIUM MAGNESIUM STEARATE GELATIN TITANIUM DIOXIDE FERRIC OXIDE YELLOW

Product Characteristics Color yellow Score no score Shape CAPSULE Size 5mm Flavor Imprint Code PBT;0;5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69452-153-20 100 CAPSULE, GELATIN COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090802 02/26/2016

TACROLIMUS tacrolimus capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-154 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 HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) CROSCARMELLOSE SODIUM MAGNESIUM STEARATE GELATIN TITANIUM DIOXIDE

Product Characteristics Color white Score no score Shape CAPSULE Size 5mm Flavor Imprint Code PBT;1;0 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69452-154-20 100 CAPSULE, GELATIN COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090802 02/26/2016

TACROLIMUS tacrolimus capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-155 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 HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) CROSCARMELLOSE SODIUM MAGNESIUM STEARATE GELATIN TITANIUM DIOXIDE FERRIC OXIDE YELLOW

Product Characteristics Color pink Score no score Shape CAPSULE Size 4mm Flavor Imprint Code PBT;5;0 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69452-155-20 100 CAPSULE, GELATIN COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090802 02/26/2016

Labeler — BionPharma Inc., (079637826)

Registrant — Panacea Biotec Pharma Limited (878533279)

Establishment
Name	Address	ID/FEI	Operations
Panacea Biotec Pharma Limited		857979552	manufacture (69452-153), manufacture (69452-154), manufacture (69452-155)

Revised: 12/2020 BionPharma Inc.,