Sirolimus

SIROLIMUS — sirolimus tablet, film coated
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sirolimus Tablets, 0.5 mg

NDC 65841-771-01

100 Tablets

Rx only

Sirolimus Tablets, 1 mg

NDC 65841-772-01

100 Tablets

Rx only

Sirolimus Tablets, 2 mg

NDC 65841-773-01

100 Tablets

Rx only

SIROLIMUS sirolimus tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-771 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SIROLIMUS (SIROLIMUS) SIROLIMUS 0.5 mg

Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSPOVIDONE (15 MPA.S AT 5%) FD&C YELLOW NO. 5 FERRIC OXIDE YELLOW GLYCERYL OLEATE HYPROMELLOSES LACTOSE MONOHYDRATE POLOXAMER 188 POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SUCROSE TALC TITANIUM DIOXIDE

Product Characteristics Color YELLOW (YELLOW) Score no score Shape ROUND (ROUND) Size 5mm Flavor Imprint Code 1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-771-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65841-771-06 30 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:65841-771-16 90 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:65841-771-05 500 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:65841-771-10 1000 TABLET, FILM COATED in 1 BOTTLE None 6 NDC:65841-771-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-771-30) 6 NDC:65841-771-30 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-771-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201676 01/15/2014

SIROLIMUS sirolimus tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-772 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SIROLIMUS (SIROLIMUS) SIROLIMUS 1 mg

Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSPOVIDONE (120 .MU.M) GLYCERYL OLEATE HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE POLOXAMER 188 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 6000 POVIDONE K30 SUCROSE TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 11 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-772-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65841-772-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-772-30) 2 NDC:65841-772-30 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-772-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201676 02/16/2023

SIROLIMUS sirolimus tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-773 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SIROLIMUS (SIROLIMUS) SIROLIMUS 2 mg

Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSPOVIDONE (120 .MU.M) FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL OLEATE HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE POLOXAMER 188 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 8000 POVIDONE K30 SUCROSE TALC TITANIUM DIOXIDE

Product Characteristics Color YELLOW (YELLOW) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 21 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-773-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65841-773-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-773-30) 2 NDC:65841-773-30 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-773-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201676 02/16/2023

Labeler — Zydus Lifesciences Limited (918596198)

Registrant — Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		918596198	ANALYSIS (65841-771), ANALYSIS (65841-772), ANALYSIS (65841-773), MANUFACTURE (65841-771), MANUFACTURE (65841-772), MANUFACTURE (65841-773)

Revised: 02/2023 Zydus Lifesciences Limited