FDA.reportPublic FDA data

Sirolimus

Product NDC
66689-347
11-digit product format
666890347
Labeler code
66689
Product ID
66689-347_909758a8-92f7-443a-bfe1-3f2f6cb98eb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sirolimus
Dosage form
SOLUTION
Route
ORAL
Labeler
VistaPharm, LLC
Application
ANDA211040
Marketing category
ANDA
Marketing start
2019-01-28
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
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
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
66689-347-022024-01-30C16284748780-11030e365-0662-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66689-347-02Sirolimus1 in 1 CARTONSOLUTION111
66689-347-02Sirolimus1 in 1 KITSOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-347-02ML - Milliliter66689-347e47c72cf-3e00-43b9-88bb-cdb65c84267012019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-347SIROLIMUS SOLUTION [VISTAPHARM, LLC]10Current NDC, Legacy NDC, 2 package rows20240209_19880f51-badb-4846-a02a-592a210690ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314230sirolimus 1 MG in 1 mL Oral SolutionPSN19880f51-badb-4846-a02a-592a210690ab11
314230sirolimus 1 MG/ML Oral SolutionSCD19880f51-badb-4846-a02a-592a210690ab11
314230sirolimus 1 MG per 1 ML Oral SolutionSY19880f51-badb-4846-a02a-592a210690ab11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-347-02666890347021 CARTON in 1 KIT (66689-347-02) / 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE1 carton2019-01-280000-00-00NoNoCurrent