FDA.reportPublic FDA data

Sirolimus

Manufacturer
AX Pharmaceutical Corp
Effective date
2026-06-26
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
4
Source
monthly-update
Hydrated at
2026-07-17 21:37:34

Label at a glance#

ProductSirolimus
Active ingredientSIROLIMUS
Label structure1 sections

Label contents#

Full prescribing information#

Sirolimus

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e68235d1-1e8b-9d8c-fddb-764b8b692c25Product name720250331
9344cc31-0398-4e2f-a65e-a24a0de47fc4Product name120230103
741e13fe-61d8-4a4c-8c27-eb206b28f1bfProduct name120220613

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73377-07473377-074-01, 73377-074-02, 73377-074-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SIROLIMUSW36ZG6FT64ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-02-12full-release2026-06-01 02:51:26

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SirolimusSIROLIMUSREMEDYREPACK INC.fc81cb86-61e1-4622-b2ce-cde263143aa02026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
sirolimusSIROLIMUSAmerican Health Packaginga71c205f-7acc-40e5-9eee-69daeb49a3522026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sirolimus
generic name: SIROLIMUS
sirolimusSIROLIMUSNORTHSTAR RX LLCad39eb60-1fa0-4722-8ba1-523194921c2a2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sirolimus
generic name: SIROLIMUS
sirolimusSIROLIMUSBryant Ranch Prepackf9843d49-0e16-4427-9cea-9f66f32b97f72026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sirolimus
generic name: SIROLIMUS
SirolimusSIROLIMUSMylan Pharmaceuticals Inc.5908cd1a-fc5a-462f-99ed-1d8983e253c92026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
SirolimusSIROLIMUSAvPAK6a85ad01-8144-4d9c-e053-2991aa0a4f852026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
sirolimusSIROLIMUSGlenmark Pharmaceuticals Inc., USA57fb4d90-3ccb-4a69-af1e-53be83f7a5042026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sirolimus
generic name: SIROLIMUS
SirolimusSIROLIMUSMajor Pharmaceuticals1bef7d8f-524b-4218-8fef-6c3f3628d33e2025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
SirolimusSIROLIMUSRising Pharma Holdings, Inc.400da0a5-2a85-44ab-a2c5-bb9161750db32025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
SirolimusSIROLIMUSAscend Laboratories, LLCcdc49844-3e77-41d3-8287-b16d0c4742c52025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
sirolimusSIROLIMUSNorthstar Rx LLC848b53ea-cdb6-45f8-bc70-8600d2dd6dce2025-08-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sirolimus
generic name: SIROLIMUS
HYFTORSIROLIMUSNobelpharma America, LLCedb3ea90-5adc-48ec-99f5-ab963e302f182025-08-22Warnings, Adverse reactionsName fallback
generic name: SIROLIMUS
SirolimusSIROLIMUSAmerican Health Packaging5df60452-2b16-4ce9-8c29-48798a59d7182025-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
SirolimusSIROLIMUSREMEDYREPACK INC.74549ff2-74dc-449d-9a01-087260f9f8be2025-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
sirolimusSIROLIMUSREMEDYREPACK INC.09f24e7a-0bea-4e02-b557-c60eb842d41a2025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sirolimus
generic name: SIROLIMUS
sirolimusSIROLIMUSNovadoz Pharmaceuticals LLC580c1ec1-c1f5-45f6-89b7-3be25c07a0e52025-03-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sirolimus
generic name: SIROLIMUS
SIROLIMUSSIROLIMUSCamber Pharmaceuticals, Inc.80269e86-3b04-44d0-9bff-7e7129e8ccb32024-11-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SIROLIMUS
generic name: SIROLIMUS
SirolimusSIROLIMUSVistaPharm, LLC19880f51-badb-4846-a02a-592a210690ab2024-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
SirolimusSIROLIMUSDr. Reddy's Laboratories Limited2e6130e5-fa94-dcf8-605c-817bf396e93d2023-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sirolimus
generic name: SIROLIMUS
sirolimusSIROLIMUSZydus Lifesciences Limited82562b68-224d-482a-b399-a89b81d5eb312023-09-27Name fallback
brand name: sirolimus
generic name: SIROLIMUS

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.