FDA.reportPublic FDA data

EVEROLIMUS

Product NDC
70377-012
11-digit product format
703770012
Labeler code
70377
Product ID
70377-012_4e63b36e-3d75-b3b0-42b6-f2f3c1ddf4d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA214182
Marketing category
ANDA
Marketing start
2021-10-01
Substance
EVEROLIMUS
Active strength
7.5 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
EVEROLIMUS7.5 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
70377-012-11EVEROLIMUS30 in 1 BOTTLETABLET3011
70377-012-22EVEROLIMUS7 in 1 BLISTER PACKTABLET711
70377-012-22EVEROLIMUS4 in 1 CARTONTABLET411
70377-012-23EVEROLIMUS7 in 1 BLISTER PACKTABLET711
70377-012-23EVEROLIMUS4 in 1 CARTONTABLET411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-012-11EA - Each70377-01204f52834-463c-483f-9245-bca521ba740512023-10-16
70377-012-22EA - Each70377-012588ae5e9-c1be-4f3e-840a-6f8a3db6d4ef12021-11-09
70377-012-23EA - Each70377-01242279cd9-4fd1-42f8-9a63-f6fb352c0c1712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-012EVEROLIMUS TABLET [BIOCON PHARMA INC.]11Current NDC, Legacy NDC, 5 package rows20250508_5fb55800-f322-6bb6-9dde-622925ef28bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845507everolimus 10 MG Oral TabletPSN5fb55800-f322-6bb6-9dde-622925ef28bd11
998189everolimus 2.5 MG Oral TabletPSN5fb55800-f322-6bb6-9dde-622925ef28bd11
845515everolimus 5 MG Oral TabletPSN5fb55800-f322-6bb6-9dde-622925ef28bd11
1119400everolimus 7.5 MG Oral TabletPSN5fb55800-f322-6bb6-9dde-622925ef28bd11
845507everolimus 10 MG Oral TabletSCD5fb55800-f322-6bb6-9dde-622925ef28bd11
998189everolimus 2.5 MG Oral TabletSCD5fb55800-f322-6bb6-9dde-622925ef28bd11
845515everolimus 5 MG Oral TabletSCD5fb55800-f322-6bb6-9dde-622925ef28bd11
1119400everolimus 7.5 MG Oral TabletSCD5fb55800-f322-6bb6-9dde-622925ef28bd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70377-012-117037700121130 TABLET in 1 BOTTLE (70377-012-11) 30 tablet2023-06-08NoNoHistorical
70377-012-22703770012224 BLISTER PACK in 1 CARTON (70377-012-22) / 7 TABLET in 1 BLISTER PACK4 blister pack2021-10-010000-00-00NoNoCurrent
70377-012-23703770012234 BLISTER PACK in 1 CARTON (70377-012-23) / 7 TABLET in 1 BLISTER PACK4 blister pack2024-05-17NoNoHistorical