Sirolimus

SIROLIMUS- sirolimus tablet, film coated
Zydus Lifesciences Limited

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sirolimus Tablets, 0.5 mg

NDC 65841-771-01

100 Tablets

Rx only

Sirolimus Tablets,  0.5 mg
(click image for full-size original)

Sirolimus Tablets, 1 mg

NDC 65841-772-01

100 Tablets

Rx only

1 mg label
(click image for full-size original)

Sirolimus Tablets, 2 mg

NDC 65841-773-01

100 Tablets

Rx only

2 mg label
(click image for full-size original)
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: 09/2023 Zydus Lifesciences Limited

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