FDA.reportPublic FDA data

EVEROLIMUS

Product NDC
60219-2281
11-digit product format
602192281
Labeler code
60219
Product ID
60219-2281_f17d8812-cd63-49d9-984d-ae170f0bc74d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
everolimus
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA218863
Marketing category
ANDA
Marketing start
2025-01-14
Substance
EVEROLIMUS
Active strength
5 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
EVEROLIMUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EVEROLIMUS5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9HW64Q8G6G
Rxcui1308428, 1308430, 1308432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
807eb842-6749-6eff-f9ce-2751c69fde93Product name420260122
151279ee-9f3c-b884-3327-05b3fa99d863Product name620251027

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-2281-1EVEROLIMUS7 in 1 BLISTER PACKTABLET, FOR SUSPENSION74
60219-2281-2EVEROLIMUS4 in 1 CARTONTABLET, FOR SUSPENSION44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2281-1EA - Each60219-22815110228f-3628-4deb-9485-374568bff3a412025-02-10
60219-2281-2EA - Each60219-22811bc5ee5b-5078-478e-adac-90a9a5644e8512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-2281EVEROLIMUS TABLET, FOR SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC]3Current NDC, 2 package rows20250114_6f1ae129-c21e-4c25-84c1-a6757d9a7eb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1308428everolimus 2 MG Tablet for Oral SuspensionPSN6f1ae129-c21e-4c25-84c1-a6757d9a7eb24
1308430everolimus 3 MG Tablet for Oral SuspensionPSN6f1ae129-c21e-4c25-84c1-a6757d9a7eb24
1308432everolimus 5 MG Tablet for Oral SuspensionPSN6f1ae129-c21e-4c25-84c1-a6757d9a7eb24
1308428everolimus 2 MG Tablet for Oral SuspensionSCD6f1ae129-c21e-4c25-84c1-a6757d9a7eb24
1308430everolimus 3 MG Tablet for Oral SuspensionSCD6f1ae129-c21e-4c25-84c1-a6757d9a7eb24
1308432everolimus 5 MG Tablet for Oral SuspensionSCD6f1ae129-c21e-4c25-84c1-a6757d9a7eb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-2281-1602192281017 in 1 BLISTER PACKHistorical
60219-2281-2602192281024 BLISTER PACK in 1 CARTON (60219-2281-2) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2281-1) 4 blister pack2025-01-14NoNoHistorical