EVEROLIMUS

Product NDC
72603-255
11-digit product format
726030255
Labeler code
72603
Product ID
72603-255_10865ecf-d37f-4062-ec4e-b8c8a9c36897
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
everolimus
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA214182
Marketing category
ANDA
Marketing start
2024-10-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EVEROLIMUS
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-255-01EVEROLIMUS30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-255-01EA - Each72603-25535c38a25-d4b6-4bf7-99ad-93dc297f7eef12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-255EVEROLIMUS TABLET [NORTHSTAR RXLLC]1Current NDC, 1 package rows20241001_5cfca904-b75c-5a39-8cb9-b99bb421bceb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845507everolimus 10 MG Oral TabletPSN5cfca904-b75c-5a39-8cb9-b99bb421bceb2
998189everolimus 2.5 MG Oral TabletPSN5cfca904-b75c-5a39-8cb9-b99bb421bceb2
845515everolimus 5 MG Oral TabletPSN5cfca904-b75c-5a39-8cb9-b99bb421bceb2
1119400everolimus 7.5 MG Oral TabletPSN5cfca904-b75c-5a39-8cb9-b99bb421bceb2
845507everolimus 10 MG Oral TabletSCD5cfca904-b75c-5a39-8cb9-b99bb421bceb2
998189everolimus 2.5 MG Oral TabletSCD5cfca904-b75c-5a39-8cb9-b99bb421bceb2
845515everolimus 5 MG Oral TabletSCD5cfca904-b75c-5a39-8cb9-b99bb421bceb2
1119400everolimus 7.5 MG Oral TabletSCD5cfca904-b75c-5a39-8cb9-b99bb421bceb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-255-017260302550130 TABLET in 1 BOTTLE (72603-255-01) 30 tablet2024-10-01NoNoHistorical