FDA.reportPublic FDA data

sirolimus 0.5 MG Oral Tablet

RxCUI
905158
RxNorm name
sirolimus 0.5 MG Oral Tablet
Display name
sirolimus 0.5 MG Oral Tablet
Full name
sirolimus 0.5 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sirolimusSIROLIMUSAmerican Health Packaginga71c205f-7acc-40e5-9eee-69daeb49a3522026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 905158
sirolimusSIROLIMUSNORTHSTAR RX LLCad39eb60-1fa0-4722-8ba1-523194921c2a2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 905158
SirolimusSIROLIMUSMylan Pharmaceuticals Inc.5908cd1a-fc5a-462f-99ed-1d8983e253c92026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 905158
sirolimusSIROLIMUSGlenmark Pharmaceuticals Inc., USA57fb4d90-3ccb-4a69-af1e-53be83f7a5042026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 905158
SirolimusSIROLIMUSAscend Laboratories, LLCcdc49844-3e77-41d3-8287-b16d0c4742c52025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 905158
sirolimusSIROLIMUSREMEDYREPACK INC.9970e495-29c4-47b8-a3e9-c9b365abe4002025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 905158
SirolimusSIROLIMUSREMEDYREPACK INC.74549ff2-74dc-449d-9a01-087260f9f8be2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 905158
sirolimusSIROLIMUSREMEDYREPACK INC.09f24e7a-0bea-4e02-b557-c60eb842d41a2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 905158
sirolimusSIROLIMUSZydus Lifesciences Limited82562b68-224d-482a-b399-a89b81d5eb312023-09-27Exact identifier
rxcui: 905158
sirolimusSIROLIMUSZydus Pharmaceuticals USA Inc.ec473170-47f1-4a5c-b4d9-ac36406ed2412023-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 905158

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 9 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
5908cd1a-fc5a-462f-99ed-1d8983e253c9sirolimus 0.5 MG Oral Tablet [PSN] · sirolimus 0.5 MG Oral Tablet [SCD]222These highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 199920260326
ec473170-47f1-4a5c-b4d9-ac36406ed241sirolimus 0.5 MG Oral Tablet [PSN] · sirolimus 0.5 MG Oral Tablet [SCD]216These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 199920230720
82562b68-224d-482a-b399-a89b81d5eb31sirolimus 0.5 MG Oral Tablet [PSN] · sirolimus 0.5 MG Oral Tablet [SCD]211SIROLIMUS TABLETS20230927
cdc49844-3e77-41d3-8287-b16d0c4742c5sirolimus 0.5 MG Oral Tablet [PSN] · sirolimus 0.5 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 199920250918
ad39eb60-1fa0-4722-8ba1-523194921c2asirolimus 0.5 MG Oral Tablet [PSN] · sirolimus 0.5 MG Oral Tablet [SCD]24These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 199920260511
57fb4d90-3ccb-4a69-af1e-53be83f7a504sirolimus 0.5 MG Oral Tablet [PSN] · sirolimus 0.5 MG Oral Tablet [SCD]24These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 199920260128
74549ff2-74dc-449d-9a01-087260f9f8besirolimus 0.5 MG Oral Tablet [PSN] · sirolimus 0.5 MG Oral Tablet [SCD]24These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 199920250724
9970e495-29c4-47b8-a3e9-c9b365abe400sirolimus 0.5 MG Oral Tablet [PSN] · sirolimus 0.5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 199920250819
09f24e7a-0bea-4e02-b557-c60eb842d41asirolimus 0.5 MG Oral Tablet [PSN] · sirolimus 0.5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 199920250630