Label: SIROLIMUS tablet, film coated
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NDC Code(s):
65841-771-01,
65841-771-05,
65841-771-06,
65841-771-10, view more65841-771-16, 65841-771-30, 65841-771-77, 65841-772-01, 65841-772-30, 65841-772-77, 65841-773-01, 65841-773-30, 65841-773-77
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 16, 2023
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INGREDIENTS AND APPEARANCE
SIROLIMUS
sirolimus tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-771 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64) SIROLIMUS 0.5 mg Inactive Ingredients Ingredient Name Strength 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 Color YELLOW (YELLOW) Score no score Shape ROUND (ROUND) Size 5mm Flavor Imprint Code 1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-771-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2014 2 NDC:65841-771-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2014 3 NDC:65841-771-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2014 4 NDC:65841-771-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2014 5 NDC:65841-771-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2014 6 NDC:65841-771-77 10 in 1 CARTON 01/15/2014 6 NDC:65841-771-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201676 01/15/2014 SIROLIMUS
sirolimus tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-772 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64) SIROLIMUS 1 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-772-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2023 2 NDC:65841-772-77 10 in 1 CARTON 02/16/2023 2 NDC:65841-772-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201676 02/16/2023 SIROLIMUS
sirolimus tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-773 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64) SIROLIMUS 2 mg Inactive Ingredients Ingredient Name Strength 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 Color YELLOW (YELLOW) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 21 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-773-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2023 2 NDC:65841-773-77 10 in 1 CARTON 02/16/2023 2 NDC:65841-773-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 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 Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-771, 65841-772, 65841-773) , MANUFACTURE(65841-771, 65841-772, 65841-773)
