Everolimus

Product NDC
49884-128
11-digit product format
498840128
Labeler code
49884
Product ID
49884-128_131a5a57-ee0b-4ee9-9c61-9be3dcdcbb25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA207934
Marketing category
ANDA
Marketing start
2022-11-29
Marketing end
0000-00-00
Substance
EVEROLIMUS
Active strength
10 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
2023-12-31
Current FDA listing
Historical FDA.report record

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
49884-128-52Everolimus7 in 1 BLISTER PACKTABLET723
49884-128-91Everolimus4 in 1 CARTONTABLET423

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-128-52EA - Each49884-1287394f33d-a2e6-4d84-bbfb-a71ce235517412022-12-07
49884-128-91EA - Each49884-12800b01df4-be43-47b2-ba0b-fc17cd0a049112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-128EVEROLIMUS TABLET [ENDO USA, INC.]21Legacy 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
49884-128-52498840128527 in 1 BLISTER PACKHistorical
49884-128-91498840128914 BLISTER PACK in 1 CARTON (49884-128-91) > 7 TABLET in 1 BLISTER PACK (49884-128-52) 4 blister pack2022-11-290000-00-00NoNoCurrent