FDA.reportPublic FDA data

Everolimus

Product NDC
51991-985
11-digit product format
519910985
Labeler code
51991
Product ID
51991-985_e7f5ef4d-6763-4908-9b64-c2a2f600b2c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus tablets
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA205432
Marketing category
ANDA
Marketing start
2025-10-30
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
51991-985-06Everolimus60 in 1 BOTTLETABLET608
51991-985-60Everolimus10 in 1 BLISTER PACKTABLET108
51991-985-99Everolimus60 in 1 CARTONTABLET608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-985-06EA - Each51991-9854d757a4e-aa90-4796-9ff5-68bcd802149712025-11-13
51991-985-60EA - Each51991-985445fcfde-6ade-455b-ab71-21807edcf8b712025-11-13
51991-985-99EA - Each51991-98518a281b2-37e7-423a-8c58-2da6a13cfd1a12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977427everolimus 0.25 MG Oral TabletPSNc7bb6ba1-9a7f-43f5-b058-ef26d4b592218
977434everolimus 0.5 MG Oral TabletPSNc7bb6ba1-9a7f-43f5-b058-ef26d4b592218
977438everolimus 0.75 MG Oral TabletPSNc7bb6ba1-9a7f-43f5-b058-ef26d4b592218
2056895everolimus 1 MG Oral TabletPSNc7bb6ba1-9a7f-43f5-b058-ef26d4b592218
977427everolimus 0.25 MG Oral TabletSCDc7bb6ba1-9a7f-43f5-b058-ef26d4b592218
977434everolimus 0.5 MG Oral TabletSCDc7bb6ba1-9a7f-43f5-b058-ef26d4b592218
977438everolimus 0.75 MG Oral TabletSCDc7bb6ba1-9a7f-43f5-b058-ef26d4b592218
2056895everolimus 1 MG Oral TabletSCDc7bb6ba1-9a7f-43f5-b058-ef26d4b592218
977434everolimus 500 MCG Oral TabletSYc7bb6ba1-9a7f-43f5-b058-ef26d4b592218
977438everolimus 750 MCG Oral TabletSYc7bb6ba1-9a7f-43f5-b058-ef26d4b592218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51991-985-065199109850660 TABLET in 1 BOTTLE (51991-985-06) 60 tablet2025-10-30NoNoHistorical
51991-985-605199109856010 in 1 BLISTER PACKHistorical
51991-985-995199109859960 BLISTER PACK in 1 CARTON (51991-985-99) / 10 TABLET in 1 BLISTER PACK (51991-985-60) 60 blister pack2025-10-30NoNoHistorical