FDA.reportPublic FDA data

Everolimus

Product NDC
63850-0107
11-digit product format
638500107
Labeler code
63850
Product ID
63850-0107_111c2e93-390f-40c6-a626-6aa45878a801
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Natco Pharma Limited
Application
ANDA205432
Marketing category
ANDA
Marketing start
2021-05-20
Substance
EVEROLIMUS
Active strength
1 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
EVEROLIMUS1 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
63850-0107-1Everolimus10 in 1 BLISTER PACKTABLET105
63850-0107-2Everolimus60 in 1 CARTONTABLET605
63850-0107-3Everolimus60 in 1 BOTTLETABLET605

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977427everolimus 0.25 MG Oral TabletPSNd44998bb-5deb-4ee7-a0a5-979fe3f495575
977434everolimus 0.5 MG Oral TabletPSNd44998bb-5deb-4ee7-a0a5-979fe3f495575
977438everolimus 0.75 MG Oral TabletPSNd44998bb-5deb-4ee7-a0a5-979fe3f495575
2056895everolimus 1 MG Oral TabletPSNd44998bb-5deb-4ee7-a0a5-979fe3f495575
977427everolimus 0.25 MG Oral TabletSCDd44998bb-5deb-4ee7-a0a5-979fe3f495575
977434everolimus 0.5 MG Oral TabletSCDd44998bb-5deb-4ee7-a0a5-979fe3f495575
977438everolimus 0.75 MG Oral TabletSCDd44998bb-5deb-4ee7-a0a5-979fe3f495575
2056895everolimus 1 MG Oral TabletSCDd44998bb-5deb-4ee7-a0a5-979fe3f495575
977434everolimus 500 MCG Oral TabletSYd44998bb-5deb-4ee7-a0a5-979fe3f495575
977438everolimus 750 MCG Oral TabletSYd44998bb-5deb-4ee7-a0a5-979fe3f495575

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63850-0107-16385001070110 in 1 BLISTER PACKHistorical
63850-0107-26385001070260 BLISTER PACK in 1 CARTON (63850-0107-2) / 10 TABLET in 1 BLISTER PACK (63850-0107-1) 60 blister pack2025-10-14NoNoHistorical
63850-0107-36385001070360 TABLET in 1 BOTTLE (63850-0107-3) 60 tablet2025-10-14NoNoHistorical