FDA.reportPublic FDA data

everolimus

Product NDC
82293-031
11-digit product format
822930031
Labeler code
82293
Product ID
82293-031_4ca7b927-0d89-0be6-e063-6394a90af200
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Novugen Pharma (USA) LLC.
Application
ANDA219955
Marketing category
ANDA
Marketing start
2026-03-30
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219955-001EVEROLIMUSEVEROLIMUS2.5MGTABLET / ORALAB2025-10-30
A219955-002EVEROLIMUSEVEROLIMUS5MGTABLET / ORALAB2025-10-30
A219955-003EVEROLIMUSEVEROLIMUS7.5MGTABLET / ORALAB2025-10-30
A219955-004EVEROLIMUSEVEROLIMUS10MGTABLET / ORALAB2025-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A219955-001AB
A219955-002AB
A219955-003AB
A219955-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A219955-001EVEROLIMUS2.5MGTABLET / ORALAB2025-10-30a50c72e98297…
2026-08-01 22:54:322026-06A219955-002EVEROLIMUS5MGTABLET / ORALAB2025-10-30a50c72e98297…
2026-08-01 22:54:322026-06A219955-003EVEROLIMUS7.5MGTABLET / ORALAB2025-10-30a50c72e98297…
2026-08-01 22:54:322026-06A219955-004EVEROLIMUS10MGTABLET / ORALAB2025-10-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A219955-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A219955-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A219955-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A219955-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
everolimusEVEROLIMUSNovugen Pharma (USA) LLC.67e62e26-448d-46ec-b5a1-00dc1b5e26c62026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219955
application number: ANDA219955
ndc (product): 82293-031

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9HW64Q8G6GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
845507Internal RxNorm lookup
845515Internal RxNorm lookup
998189Internal RxNorm lookup
1119400Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
67e62e26-448d-46ec-b5a1-00dc1b5e26c6Available on FDA.report

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
82293-031-10everolimus28 in 1 BOTTLETABLET281
82293-031-20everolimus7 in 1 BLISTER PACKTABLET71
82293-031-21everolimus4 in 1 CARTONTABLET41
82293-031-30everolimus10 in 1 BLISTER PACKTABLET101
82293-031-31everolimus1 in 1 CARTONTABLET11
82293-031-31everolimus3 in 1 POUCHTABLET31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-031-20EA - Each82293-031920c4cc1-2685-40b8-a75b-ba6d345abf5112026-05-22
82293-031-21EA - Each82293-031363c4dae-4aaf-4f45-b0a5-35ac1fa3a60912026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845507everolimus 10 MG Oral TabletPSN67e62e26-448d-46ec-b5a1-00dc1b5e26c61
998189everolimus 2.5 MG Oral TabletPSN67e62e26-448d-46ec-b5a1-00dc1b5e26c61
845515everolimus 5 MG Oral TabletPSN67e62e26-448d-46ec-b5a1-00dc1b5e26c61
1119400everolimus 7.5 MG Oral TabletPSN67e62e26-448d-46ec-b5a1-00dc1b5e26c61
845507everolimus 10 MG Oral TabletSCD67e62e26-448d-46ec-b5a1-00dc1b5e26c61
998189everolimus 2.5 MG Oral TabletSCD67e62e26-448d-46ec-b5a1-00dc1b5e26c61
845515everolimus 5 MG Oral TabletSCD67e62e26-448d-46ec-b5a1-00dc1b5e26c61
1119400everolimus 7.5 MG Oral TabletSCD67e62e26-448d-46ec-b5a1-00dc1b5e26c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82293-031-108229300311028 TABLET in 1 BOTTLE (82293-031-10) 28 tablet2026-03-30NoNoCurrent
82293-031-20822930031207 in 1 BLISTER PACKHistorical
82293-031-21822930031214 BLISTER PACK in 1 CARTON (82293-031-21) / 7 TABLET in 1 BLISTER PACK (82293-031-20) 4 blister pack2026-03-30NoNoCurrent
82293-031-308229300313010 in 1 BLISTER PACKHistorical
82293-031-31822930031311 POUCH in 1 CARTON (82293-031-31) / 3 BLISTER PACK in 1 POUCH / 10 TABLET in 1 BLISTER PACK (82293-031-30) 1 pouch2026-03-30NoNoCurrent