FDA.reportPublic FDA data

Sirolimus

Product NDC
59762-1205
11-digit product format
597621205
Labeler code
59762
Product ID
59762-1205_1501a154-5d23-4ff0-a6ef-31715dcb2282
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sirolimus
Dosage form
SOLUTION
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021083
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-07-22
Substance
SIROLIMUS
Active strength
1 mg/mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sirolimus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIROLIMUS1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW36ZG6FT64
Rxcui314230

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
59762-1205-62023-11-21C16284748780-10191ceaa-6723-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS oral solution Initial U.S. Approval: 1999
59762-1205-62023-07-28C16284748780-10191ceaa-6723-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS oral solution Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-1205-4Sirolimus60 mL in 1 BOTTLE, GLASSSOLUTION6017
59762-1205-4Sirolimus1 in 1 CARTONSOLUTION117
59762-1205-6Sirolimus1 in 1 KITSOLUTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1205-4ML - Milliliter59762-1205e44188b9-4bd1-4d4f-acac-d3f3eb44ffbf12021-06-02
59762-1205-6ML - Milliliter59762-12056f8b1813-ce03-4645-b869-cf572f6ba77e12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1205SIROLIMUS SOLUTION [MYLAN PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 3 package rows20250529_384cb547-55a4-47fc-a0a6-054c18a51b84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314230sirolimus 1 MG in 1 mL Oral SolutionPSN384cb547-55a4-47fc-a0a6-054c18a51b8417
314230sirolimus 1 MG/ML Oral SolutionSCD384cb547-55a4-47fc-a0a6-054c18a51b8417
314230sirolimus 1 MG per 1 ML Oral SolutionSY384cb547-55a4-47fc-a0a6-054c18a51b8417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-1205-45976212050460 mL in 1 BOTTLE, GLASS60 mlHistorical
59762-1205-6597621205061 CARTON in 1 KIT (59762-1205-6) / 1 BOTTLE, GLASS in 1 CARTON (59762-1205-4) / 60 mL in 1 BOTTLE, GLASS1 carton2019-07-220000-00-00NoNoCurrent