everolimus

Product NDC
59651-933
11-digit product format
596510933
Labeler code
59651
Product ID
59651-933_43ef3c29-0e25-4fdd-aea1-06a20af9bbab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA219533
Marketing category
ANDA
Marketing start
2026-02-25
Substance
EVEROLIMUS
Active strength
.75 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
EVEROLIMUS.75 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
59651-933-60everolimus60 in 1 BOTTLETABLET601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977427everolimus 0.25 MG Oral TabletPSN43ef3c29-0e25-4fdd-aea1-06a20af9bbab1
977434everolimus 0.5 MG Oral TabletPSN43ef3c29-0e25-4fdd-aea1-06a20af9bbab1
977438everolimus 0.75 MG Oral TabletPSN43ef3c29-0e25-4fdd-aea1-06a20af9bbab1
2056895everolimus 1 MG Oral TabletPSN43ef3c29-0e25-4fdd-aea1-06a20af9bbab1
977427everolimus 0.25 MG Oral TabletSCD43ef3c29-0e25-4fdd-aea1-06a20af9bbab1
977434everolimus 0.5 MG Oral TabletSCD43ef3c29-0e25-4fdd-aea1-06a20af9bbab1
977438everolimus 0.75 MG Oral TabletSCD43ef3c29-0e25-4fdd-aea1-06a20af9bbab1
2056895everolimus 1 MG Oral TabletSCD43ef3c29-0e25-4fdd-aea1-06a20af9bbab1
977434everolimus 500 MCG Oral TabletSY43ef3c29-0e25-4fdd-aea1-06a20af9bbab1
977438everolimus 750 MCG Oral TabletSY43ef3c29-0e25-4fdd-aea1-06a20af9bbab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-933-605965109336060 TABLET in 1 BOTTLE (59651-933-60) 60 tablet2026-02-25NoNoHistorical