FDA.reportPublic FDA data

Everolimus

Product NDC
67877-718
11-digit product format
678770718
Labeler code
67877
Product ID
67877-718_33247fe5-9b47-4513-93fe-fc65e4c1b63f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA214138
Marketing category
ANDA
Marketing start
2021-11-27
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
67877-718-31Everolimus6 in 1 CARTONTABLET69
67877-718-33Everolimus10 in 1 BLISTER PACKTABLET109
67877-718-60Everolimus60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-718-31EA - Each67877-718e0456e23-5dfc-4d01-8855-bbfdbb9fe5c812022-01-06
67877-718-33EA - Each67877-718965bf0e5-5c79-40a4-aba2-38c03a58e99f12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-718EVEROLIMUS TABLET [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 3 package rows20240710_2693c497-a70b-4d00-b6db-602c872e5bed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977427everolimus 0.25 MG Oral TabletPSN2693c497-a70b-4d00-b6db-602c872e5bed9
977434everolimus 0.5 MG Oral TabletPSN2693c497-a70b-4d00-b6db-602c872e5bed9
977438everolimus 0.75 MG Oral TabletPSN2693c497-a70b-4d00-b6db-602c872e5bed9
2056895everolimus 1 MG Oral TabletPSN2693c497-a70b-4d00-b6db-602c872e5bed9
977427everolimus 0.25 MG Oral TabletSCD2693c497-a70b-4d00-b6db-602c872e5bed9
977434everolimus 0.5 MG Oral TabletSCD2693c497-a70b-4d00-b6db-602c872e5bed9
977438everolimus 0.75 MG Oral TabletSCD2693c497-a70b-4d00-b6db-602c872e5bed9
2056895everolimus 1 MG Oral TabletSCD2693c497-a70b-4d00-b6db-602c872e5bed9
977434everolimus 500 MCG Oral TabletSY2693c497-a70b-4d00-b6db-602c872e5bed9
977438everolimus 750 MCG Oral TabletSY2693c497-a70b-4d00-b6db-602c872e5bed9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-718-31678770718316 BLISTER PACK in 1 CARTON (67877-718-31) / 10 TABLET in 1 BLISTER PACK (67877-718-33) 6 blister pack2021-11-270000-00-00NoNoCurrent
67877-718-336787707183310 in 1 BLISTER PACKHistorical
67877-718-606787707186060 TABLET in 1 BOTTLE (67877-718-60) 60 tablet2024-03-01NoNoCurrent