FDA.reportPublic FDA data

Everolimus

Product NDC
49884-159
11-digit product format
498840159
Labeler code
49884
Product ID
49884-159_bf8637b9-79c5-42fc-8de0-b6209ad745f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA205775
Marketing category
ANDA
Marketing start
2022-03-31
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
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.5 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
49884-159-02Everolimus6 in 1 CARTONTABLET615
49884-159-52Everolimus10 in 1 BLISTER PACKTABLET1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-159-02EA - Each49884-159dde154f6-9dde-4821-98de-f9431af2a55812023-04-07
49884-159-52EA - Each49884-159691bf9f8-845a-4310-a9bd-d580f88d1fa012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-159EVEROLIMUS TABLET [ENDO USA, INC.]13Current NDC, Legacy NDC, 2 package rows20240802_59cb86d5-8706-4619-b074-af253d3e0b68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977427everolimus 0.25 MG Oral TabletPSN59cb86d5-8706-4619-b074-af253d3e0b6815
977434everolimus 0.5 MG Oral TabletPSN59cb86d5-8706-4619-b074-af253d3e0b6815
977438everolimus 0.75 MG Oral TabletPSN59cb86d5-8706-4619-b074-af253d3e0b6815
2056895everolimus 1 MG Oral TabletPSN59cb86d5-8706-4619-b074-af253d3e0b6815
977427everolimus 0.25 MG Oral TabletSCD59cb86d5-8706-4619-b074-af253d3e0b6815
977434everolimus 0.5 MG Oral TabletSCD59cb86d5-8706-4619-b074-af253d3e0b6815
977438everolimus 0.75 MG Oral TabletSCD59cb86d5-8706-4619-b074-af253d3e0b6815
2056895everolimus 1 MG Oral TabletSCD59cb86d5-8706-4619-b074-af253d3e0b6815
977434everolimus 500 MCG Oral TabletSY59cb86d5-8706-4619-b074-af253d3e0b6815
977438everolimus 750 MCG Oral TabletSY59cb86d5-8706-4619-b074-af253d3e0b6815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-159-02498840159026 BLISTER PACK in 1 CARTON (49884-159-02) / 10 TABLET in 1 BLISTER PACK (49884-159-52) 6 blister pack2022-03-310000-00-00NoNoCurrent
49884-159-524988401595210 in 1 BLISTER PACKHistorical