FDA.reportPublic FDA data

Afinitor

Product NDC
0078-0627
11-digit product format
000780627
Labeler code
0078
Product ID
0078-0627_79d3253f-e1e3-428f-8dd4-4f2fe76faa15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
everolimus
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA203985
Marketing category
NDA
Marketing start
2012-08-29
Substance
EVEROLIMUS
Active strength
3 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], 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
Afinitor
Brand name suffix
Disperz
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EVEROLIMUS3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9HW64Q8G6G
Rxcui845507, 845512, 845515, 845518, 998189, 998191, 1119400, 1119402, 1308428, 1308430, 1308432, 1310138, 1310144, 1310147

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
807eb842-6749-6eff-f9ce-2751c69fde93Product name420260122
151279ee-9f3c-b884-3327-05b3fa99d863Product name620251027
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-0627-512023-08-01C16284748780-10191ceaa-70f2-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009
0078-0627-512023-08-01C16284748780-10191ceaa-70f2-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009
0078-0627-512023-07-28C16284748780-10191ceaa-70f2-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009
0078-0627-512023-07-28C16284748780-10191ceaa-70f2-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0627-51AfinitorDisperz28 in 1 CARTONTABLET, FOR SUSPENSION2866
0078-0627-61AfinitorDisperz1 in 1 BLISTER PACKTABLET, FOR SUSPENSION166

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0627-51EA - Each0078-0627df10573d-fa0f-43b6-983c-dadf78bbb8d712013-05-02
0078-0627-61EA - Each0078-0627e0a0a43f-380b-4f49-8896-b7630673f96212013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EVEROLIMUSACTIVE INGREDIENT9HW64Q8G6GAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
EVEROLIMUSACTIVE MOIETY9HW64Q8G6GAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
MANNITOLINACTIVE INGREDIENT3OWL53L36AAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0627AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]64Current NDC, Legacy NDC, 2 package rows20250515_2150f73a-179b-4afc-b8ce-67c85cc72f04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845512AFINITOR 10 MG Oral TabletPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
998191AFINITOR 2.5 MG Oral TabletPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
845518AFINITOR 5 MG Oral TabletPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
1119402AFINITOR 7.5 MG Oral TabletPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
1310138AFINITOR DISPERZ 2 MG Tablet for Oral SuspensionPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
1310144AFINITOR DISPERZ 3 MG Tablet for Oral SuspensionPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
1310147AFINITOR DISPERZ 5 MG Tablet for Oral SuspensionPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
845507everolimus 10 MG Oral TabletPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
1308428everolimus 2 MG Tablet for Oral SuspensionPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
998189everolimus 2.5 MG Oral TabletPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
1308430everolimus 3 MG Tablet for Oral SuspensionPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
845515everolimus 5 MG Oral TabletPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
1308432everolimus 5 MG Tablet for Oral SuspensionPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
1119400everolimus 7.5 MG Oral TabletPSN2150f73a-179b-4afc-b8ce-67c85cc72f0466
845512everolimus 10 MG Oral Tablet [Afinitor]SBD2150f73a-179b-4afc-b8ce-67c85cc72f0466
1310138everolimus 2 MG Tablet for Oral Suspension [Afinitor]SBD2150f73a-179b-4afc-b8ce-67c85cc72f0466
998191everolimus 2.5 MG Oral Tablet [Afinitor]SBD2150f73a-179b-4afc-b8ce-67c85cc72f0466
1310144everolimus 3 MG Tablet for Oral Suspension [Afinitor]SBD2150f73a-179b-4afc-b8ce-67c85cc72f0466
845518everolimus 5 MG Oral Tablet [Afinitor]SBD2150f73a-179b-4afc-b8ce-67c85cc72f0466
1310147everolimus 5 MG Tablet for Oral Suspension [Afinitor]SBD2150f73a-179b-4afc-b8ce-67c85cc72f0466
1119402everolimus 7.5 MG Oral Tablet [Afinitor]SBD2150f73a-179b-4afc-b8ce-67c85cc72f0466
845507everolimus 10 MG Oral TabletSCD2150f73a-179b-4afc-b8ce-67c85cc72f0466
1308428everolimus 2 MG Tablet for Oral SuspensionSCD2150f73a-179b-4afc-b8ce-67c85cc72f0466
998189everolimus 2.5 MG Oral TabletSCD2150f73a-179b-4afc-b8ce-67c85cc72f0466
1308430everolimus 3 MG Tablet for Oral SuspensionSCD2150f73a-179b-4afc-b8ce-67c85cc72f0466
845515everolimus 5 MG Oral TabletSCD2150f73a-179b-4afc-b8ce-67c85cc72f0466
1308432everolimus 5 MG Tablet for Oral SuspensionSCD2150f73a-179b-4afc-b8ce-67c85cc72f0466
1119400everolimus 7.5 MG Oral TabletSCD2150f73a-179b-4afc-b8ce-67c85cc72f0466
845512Afinitor 10 MG Oral TabletSY2150f73a-179b-4afc-b8ce-67c85cc72f0466
998191Afinitor 2.5 MG Oral TabletSY2150f73a-179b-4afc-b8ce-67c85cc72f0466
845518Afinitor 5 MG Oral TabletSY2150f73a-179b-4afc-b8ce-67c85cc72f0466
1119402Afinitor 7.5 MG Oral TabletSY2150f73a-179b-4afc-b8ce-67c85cc72f0466
1310138Afinitor Disperz 2 MG Tablet for Oral SuspensionSY2150f73a-179b-4afc-b8ce-67c85cc72f0466
1310144Afinitor Disperz 3 MG Tablet for Oral SuspensionSY2150f73a-179b-4afc-b8ce-67c85cc72f0466
1310147Afinitor Disperz 5 MG Tablet for Oral SuspensionSY2150f73a-179b-4afc-b8ce-67c85cc72f0466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0627-510007806275128 BLISTER PACK in 1 CARTON (0078-0627-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61) 28 blister pack2012-08-290000-00-00NoNoCurrent
0078-0627-61000780627611 in 1 BLISTER PACKHistorical