SIROLIMUS- sirolimus tablet, film coated 
Zydus Lifesciences Limited

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SIROLIMUS TABLETS

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

Sirolimus Tablets, 1 mg

NDC 65841-772-01

100 Tablets

Rx only

1 mg label

Sirolimus Tablets, 2 mg

NDC 65841-773-01

100 Tablets

Rx only

2 mg label
SIROLIMUS 
sirolimus tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-771
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64) SIROLIMUS0.5 mg
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (YELLOW) Scoreno score
ShapeROUND (ROUND) Size5mm
FlavorImprint Code 1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-771-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
2NDC:65841-771-0630 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
3NDC:65841-771-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
4NDC:65841-771-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
5NDC:65841-771-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
6NDC:65841-771-7710 in 1 CARTON01/15/2014
6NDC:65841-771-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20167601/15/2014
SIROLIMUS 
sirolimus tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-772
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64) SIROLIMUS1 mg
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POVIDONE K30 (UNII: U725QWY32X)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 11
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-772-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/16/2023
2NDC:65841-772-7710 in 1 CARTON02/16/2023
2NDC:65841-772-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20167602/16/2023
SIROLIMUS 
sirolimus tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-773
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64) SIROLIMUS2 mg
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
POVIDONE K30 (UNII: U725QWY32X)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (YELLOW) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-773-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/16/2023
2NDC:65841-773-7710 in 1 CARTON02/16/2023
2NDC:65841-773-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20167602/16/2023
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-771, 65841-772, 65841-773) , MANUFACTURE(65841-771, 65841-772, 65841-773)

Revised: 9/2023
Document Id: 7e6e294d-cf29-40e2-91e1-9693fdcd6b6c
Set id: 82562b68-224d-482a-b399-a89b81d5eb31
Version: 11
Effective Time: 20230927
 
Zydus Lifesciences Limited