FDA.reportPublic FDA data

Sirolimus

Product NDC
59762-1001
11-digit product format
597621001
Labeler code
59762
Product ID
59762-1001_8f2761f9-9bc3-47c3-8093-6375a39d1034
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIROLIMUS
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021110
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-07
Substance
SIROLIMUS
Active strength
.5 mg/1
Pharmacologic classes
Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sirolimus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIROLIMUS.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW36ZG6FT64
Rxcui349208, 360110, 905158

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59762-1001-12024-01-30C16284748780-10191ceaa-68ba-198a-e063-dbdaa90aec3eThese 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: 1999
59762-1001-12023-11-02C16284748780-10191ceaa-68ba-198a-e063-dbdaa90aec3eThese 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: 1999
59762-1001-12023-07-28C16284748780-10191ceaa-68ba-198a-e063-dbdaa90aec3eThese 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: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-1001-1Sirolimus100 in 1 BOTTLETABLET, SUGAR COATED10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1001-1EA - Each59762-100175e9541e-9e7c-4aa4-b71e-f16f0461e7ad12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIROLIMUSACTIVE INGREDIENTW36ZG6FT64SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
SIROLIMUSACTIVE MOIETYW36ZG6FT64SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79PSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
SUCROSEINACTIVE INGREDIENTC151H8M554SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
TALCINACTIVE INGREDIENT7SEV7J4R1USIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1001SIROLIMUS TABLET, SUGAR COATED [MYLAN PHARMACEUTICALS INC.]20Current NDC, Legacy NDC, 1 package rows20250529_5908cd1a-fc5a-462f-99ed-1d8983e253c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905158sirolimus 0.5 MG Oral TabletPSN5908cd1a-fc5a-462f-99ed-1d8983e253c922
349208sirolimus 1 MG Oral TabletPSN5908cd1a-fc5a-462f-99ed-1d8983e253c922
360110sirolimus 2 MG Oral TabletPSN5908cd1a-fc5a-462f-99ed-1d8983e253c922
905158sirolimus 0.5 MG Oral TabletSCD5908cd1a-fc5a-462f-99ed-1d8983e253c922
349208sirolimus 1 MG Oral TabletSCD5908cd1a-fc5a-462f-99ed-1d8983e253c922
360110sirolimus 2 MG Oral TabletSCD5908cd1a-fc5a-462f-99ed-1d8983e253c922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-1001-159762100101100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1001-1) 2014-01-070000-00-00NoNoCurrent