FDA.reportPublic FDA data

Everolimus

Product NDC
49884-125
11-digit product format
498840125
Labeler code
49884
Product ID
49884-125_b474c768-50e2-44da-accf-f1bd3d49ab20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA207934
Marketing category
ANDA
Marketing start
2019-12-10
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Everolimus

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EVEROLIMUS5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9HW64Q8G6G
Rxcui845507, 845515, 998189, 1119400

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-125-912022-12-01C16284748780-1e4f33bdf-aebd-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use EVEROLIMUS TABLETS safely and effectively. See full prescribing information for EVEROLIMUS TABLETS. EVEROLIMUS tablets, for oral use Initial U.S. Approval: 2009
49884-125-912022-07-29C16284748780-1e4f33bdf-aebd-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use EVEROLIMUS TABLETS safely and effectively. See full prescribing information for EVEROLIMUS TABLETS. EVEROLIMUS tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-125-52Everolimus1 in 1 BLISTER PACKTABLET123
49884-125-91Everolimus28 in 1 CARTONTABLET2823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-125-52EA - Each49884-1253c5f16e7-9a4e-4526-a31b-90bedadfa79812020-01-03
49884-125-91EA - Each49884-125debe6c52-4f5c-43c4-9145-672e3f56943812020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-125EVEROLIMUS TABLET [ENDO USA, INC.]21Current NDC, Legacy NDC, 2 package rows20240709_45d54974-3fc4-4237-a2fa-3158ca1a8105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845507everolimus 10 MG Oral TabletPSN45d54974-3fc4-4237-a2fa-3158ca1a810523
998189everolimus 2.5 MG Oral TabletPSN45d54974-3fc4-4237-a2fa-3158ca1a810523
845515everolimus 5 MG Oral TabletPSN45d54974-3fc4-4237-a2fa-3158ca1a810523
1119400everolimus 7.5 MG Oral TabletPSN45d54974-3fc4-4237-a2fa-3158ca1a810523
845507everolimus 10 MG Oral TabletSCD45d54974-3fc4-4237-a2fa-3158ca1a810523
998189everolimus 2.5 MG Oral TabletSCD45d54974-3fc4-4237-a2fa-3158ca1a810523
845515everolimus 5 MG Oral TabletSCD45d54974-3fc4-4237-a2fa-3158ca1a810523
1119400everolimus 7.5 MG Oral TabletSCD45d54974-3fc4-4237-a2fa-3158ca1a810523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-125-52498840125521 in 1 BLISTER PACKHistorical
49884-125-914988401259128 BLISTER PACK in 1 CARTON (49884-125-91) / 1 TABLET in 1 BLISTER PACK (49884-125-52) 28 blister pack2019-12-102026-07-31NoNoCurrent