FDA.reportPublic FDA data

Everolimus

Product NDC
51991-823
11-digit product format
519910823
Labeler code
51991
Product ID
51991-823_fade73fb-a367-4c53-83dd-1352c3ad807b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA205426
Marketing category
ANDA
Marketing start
2021-03-05
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

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
A205426-001EVEROLIMUSEVEROLIMUS2.5MGTABLET / ORALAB2021-03-05
A205426-002EVEROLIMUSEVEROLIMUS5MGTABLET / ORALAB2021-03-05
A205426-003EVEROLIMUSEVEROLIMUS7.5MGTABLET / ORALAB2021-03-05
A205426-004EVEROLIMUSEVEROLIMUS10MGTABLET / ORALAB2021-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205426-001AB
A205426-002AB
A205426-003AB
A205426-004AB

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 22:54:322026-06A205426-001EVEROLIMUS2.5MGTABLET / ORALAB2021-03-05a50c72e98297…
2026-08-01 22:54:322026-06A205426-002EVEROLIMUS5MGTABLET / ORALAB2021-03-05a50c72e98297…
2026-08-01 22:54:322026-06A205426-003EVEROLIMUS7.5MGTABLET / ORALAB2021-03-05a50c72e98297…
2026-08-01 22:54:322026-06A205426-004EVEROLIMUS10MGTABLET / ORALAB2021-03-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205426-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205426-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205426-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A205426-004AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YulithiraEVEROLIMUSCivicaScript, LLC5e325efa-8ae6-4dac-b59b-d7c74c73186c2026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205426
application number: ANDA205426
EverolimusEVEROLIMUSBreckenridge Pharmaceutical, Inc.01f7b5fb-be0d-4adf-acd2-6899018de9662025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205426
application number: ANDA205426
ndc (product): 51991-823
EverolimusEVEROLIMUSNatco Pharma Limitede3dbbc24-7e55-4069-a305-e2cded2db6412023-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205426
application number: ANDA205426

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 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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
845507Internal RxNorm lookup
845515Internal RxNorm lookup
998189Internal RxNorm lookup
1119400Internal RxNorm lookup
1308428Internal RxNorm lookup
1308430Internal RxNorm lookup
1308432Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
01f7b5fb-be0d-4adf-acd2-6899018de966Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-823-28Everolimus4 in 1 CARTONTABLET420
51991-823-33Everolimus30 in 1 BOTTLETABLET3020
51991-823-99Everolimus7 in 1 BLISTER PACKTABLET720

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-823-28EA - Each51991-82364ceb2d8-95e6-4052-ba63-f5b4bbd623e212021-05-05
51991-823-33EA - Each51991-823ca351cbd-c4f5-46e4-8024-4594871ea49b12023-07-06
51991-823-99EA - Each51991-8236dccf610-d749-4be9-8f7c-72bce92b2cd712021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-823EVEROLIMUS TABLET EVEROLIMUS TABLET, FOR SUSPENSION [BRECKENRIDGE PHARMACEUTICAL, INC.]16Current NDC, Legacy NDC, 3 package rows20250130_01f7b5fb-be0d-4adf-acd2-6899018de966.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845507everolimus 10 MG Oral TabletPSN01f7b5fb-be0d-4adf-acd2-6899018de96620
1308428everolimus 2 MG Tablet for Oral SuspensionPSN01f7b5fb-be0d-4adf-acd2-6899018de96620
998189everolimus 2.5 MG Oral TabletPSN01f7b5fb-be0d-4adf-acd2-6899018de96620
1308430everolimus 3 MG Tablet for Oral SuspensionPSN01f7b5fb-be0d-4adf-acd2-6899018de96620
845515everolimus 5 MG Oral TabletPSN01f7b5fb-be0d-4adf-acd2-6899018de96620
1308432everolimus 5 MG Tablet for Oral SuspensionPSN01f7b5fb-be0d-4adf-acd2-6899018de96620
1119400everolimus 7.5 MG Oral TabletPSN01f7b5fb-be0d-4adf-acd2-6899018de96620
845507everolimus 10 MG Oral TabletSCD01f7b5fb-be0d-4adf-acd2-6899018de96620
1308428everolimus 2 MG Tablet for Oral SuspensionSCD01f7b5fb-be0d-4adf-acd2-6899018de96620
998189everolimus 2.5 MG Oral TabletSCD01f7b5fb-be0d-4adf-acd2-6899018de96620
1308430everolimus 3 MG Tablet for Oral SuspensionSCD01f7b5fb-be0d-4adf-acd2-6899018de96620
845515everolimus 5 MG Oral TabletSCD01f7b5fb-be0d-4adf-acd2-6899018de96620
1308432everolimus 5 MG Tablet for Oral SuspensionSCD01f7b5fb-be0d-4adf-acd2-6899018de96620
1119400everolimus 7.5 MG Oral TabletSCD01f7b5fb-be0d-4adf-acd2-6899018de96620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-823-28519910823284 BLISTER PACK in 1 CARTON (51991-823-28) / 7 TABLET in 1 BLISTER PACK (51991-823-99) 4 blister pack2021-03-050000-00-00NoNoCurrent
51991-823-335199108233330 TABLET in 1 BOTTLE (51991-823-33) 30 tablet2023-06-05NoNoCurrent
51991-823-99519910823997 in 1 BLISTER PACKHistorical