FDA.reportPublic FDA data

Everolimus

Product NDC
0054-0470
11-digit product format
000540470
Labeler code
0054
Product ID
0054-0470_496ea375-42a1-422e-88ad-0b1c6df703aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA206133
Marketing category
ANDA
Marketing start
2020-03-10
Substance
EVEROLIMUS
Active strength
.25 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EVEROLIMUS.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9HW64Q8G6G
Rxcui977427, 977434, 977438, 2056895

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
0054-0470-21Everolimus60 in 1 BOTTLETABLET608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0470-21EA - Each0054-0470b43d6680-7d73-4cac-9739-c00199eba93b12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0470EVEROLIMUS TABLET [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 1 package rows20250416_cf2dd54b-7a1d-4401-9a01-75e68235e433.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977427everolimus 0.25 MG Oral TabletPSNcf2dd54b-7a1d-4401-9a01-75e68235e4338
977434everolimus 0.5 MG Oral TabletPSNcf2dd54b-7a1d-4401-9a01-75e68235e4338
977438everolimus 0.75 MG Oral TabletPSNcf2dd54b-7a1d-4401-9a01-75e68235e4338
2056895everolimus 1 MG Oral TabletPSNcf2dd54b-7a1d-4401-9a01-75e68235e4338
977427everolimus 0.25 MG Oral TabletSCDcf2dd54b-7a1d-4401-9a01-75e68235e4338
977434everolimus 0.5 MG Oral TabletSCDcf2dd54b-7a1d-4401-9a01-75e68235e4338
977438everolimus 0.75 MG Oral TabletSCDcf2dd54b-7a1d-4401-9a01-75e68235e4338
2056895everolimus 1 MG Oral TabletSCDcf2dd54b-7a1d-4401-9a01-75e68235e4338
977434everolimus 500 MCG Oral TabletSYcf2dd54b-7a1d-4401-9a01-75e68235e4338
977438everolimus 750 MCG Oral TabletSYcf2dd54b-7a1d-4401-9a01-75e68235e4338

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0470-210005404702160 TABLET in 1 BOTTLE (0054-0470-21) 60 tablet2020-03-100000-00-00NoNoCurrent