FDA.reportPublic FDA data

Everolimus

Product NDC
70377-091
11-digit product format
703770091
Labeler code
70377
Product ID
70377-091_38b19b37-504e-24ed-7dbc-8b9f9e3fda0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA217216
Marketing category
ANDA
Marketing start
2026-01-14
Substance
EVEROLIMUS
Active strength
3 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
EVEROLIMUS3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9HW64Q8G6G
Rxcui1308428, 1308430, 1308432

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
70377-091-11Everolimus28 in 1 BOTTLETABLET, FOR SUSPENSION285
70377-091-23Everolimus7 in 1 BLISTER PACKTABLET, FOR SUSPENSION75
70377-091-23Everolimus4 in 1 CARTONTABLET, FOR SUSPENSION45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-091-23EA - Each70377-091eb216211-1e86-4979-a8c0-19eae9f09c9012026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1308428everolimus 2 MG Tablet for Oral SuspensionPSN5b809dfe-c076-07c5-207e-178c3f0d32d35
1308430everolimus 3 MG Tablet for Oral SuspensionPSN5b809dfe-c076-07c5-207e-178c3f0d32d35
1308432everolimus 5 MG Tablet for Oral SuspensionPSN5b809dfe-c076-07c5-207e-178c3f0d32d35
1308428everolimus 2 MG Tablet for Oral SuspensionSCD5b809dfe-c076-07c5-207e-178c3f0d32d35
1308430everolimus 3 MG Tablet for Oral SuspensionSCD5b809dfe-c076-07c5-207e-178c3f0d32d35
1308432everolimus 5 MG Tablet for Oral SuspensionSCD5b809dfe-c076-07c5-207e-178c3f0d32d35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70377-091-117037700911128 TABLET, FOR SUSPENSION in 1 BOTTLE (70377-091-11) 2026-01-14NoNoHistorical
70377-091-23703770091234 BLISTER PACK in 1 CARTON (70377-091-23) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK4 blister pack2026-01-14NoNoHistorical