FDA.reportPublic FDA data

Joenja

Product NDC
71274-170
11-digit product format
712740170
Labeler code
71274
Product ID
71274-170_ad61f987-e1eb-4da6-9060-cb1915d3636f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leniolisib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharming Healthcare Inc.
Application
NDA217759
Marketing category
NDA
Marketing start
2023-03-29
Substance
LENIOLISIB PHOSPHATE
Active strength
70 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Phosphoinositide 3-Kinase delta 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217759-001JOENJALENIOLISIB PHOSPHATEEQ 70MG BASETABLET / ORALRLD, RS2023-03-24

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217759-00186530922032-02-19Drug substance, Drug product2023-04-18

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217759-001NCE2028-03-24
N217759-001ODE-4302030-03-24

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 22:54:322026-06N217759-001JOENJAEQ 70MG BASETABLET / ORALRLD, RS2023-03-24a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N217759-00186530922032-02-19Drug substance, Drug product2023-04-18a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N217759-001NCE2028-03-24a50c72e98297…
2026-08-01 22:54:322026-06N217759-001ODE-4302030-03-24a50c72e98297…

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
JoenjaLENIOLISIBPharming Healthcare Inc.eefbcef8-2130-4654-8f29-b58077e082122025-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 217759
application number: NDA217759
ndc (product): 71274-170

Additional Listing Data#

Finished product
Yes
Brand name base
Joenja
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LENIOLISIB PHOSPHATE70 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3700M1H39QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2633015Internal RxNorm lookup
2633021Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eefbcef8-2130-4654-8f29-b58077e08212Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
80fc8c0f-3f28-4425-8cbd-281bdb82c168Product name120231005

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71274-170-602024-01-30C16284748780-11030e365-4dc7-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use JOENJA safely and effectively. See full prescribing information for JOENJA. JOENJA ® (leniolisib) tablets, for oral use Initial U.S. Approval: 2023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71274-170-60Joenja60 in 1 BOTTLE, PLASTICTABLET, FILM COATED606
71274-170-60Joenja1 in 1 CARTONTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71274-170-60EA - Each71274-1708c433456-c289-4432-8625-3e7a4572681112023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71274-170JOENJA (LENIOLISIB) TABLET, FILM COATED [PHARMING HEALTHCARE INC.]5Current NDC, 2 package rows20231006_eefbcef8-2130-4654-8f29-b58077e08212.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2633021Joenja 70 MG Oral TabletPSNeefbcef8-2130-4654-8f29-b58077e082126
2633015leniolisib 70 MG Oral TabletPSNeefbcef8-2130-4654-8f29-b58077e082126
2633021leniolisib 70 MG Oral Tablet [Joenja]SBDeefbcef8-2130-4654-8f29-b58077e082126
2633015leniolisib 70 MG Oral TabletSCDeefbcef8-2130-4654-8f29-b58077e082126
2633021Joenja 70 MG (equivalent to leniolisib phosphate 85.26 MG) Oral TabletSYeefbcef8-2130-4654-8f29-b58077e082126
2633021Joenja 70 MG Oral TabletSYeefbcef8-2130-4654-8f29-b58077e082126
2633015leniolisib 70 MG (equivalent to leniolisib phosphate 85.26 MG) Oral TabletSYeefbcef8-2130-4654-8f29-b58077e082126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71274-170-60712740170601 BOTTLE, PLASTIC in 1 CARTON (71274-170-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-03-29NoNoCurrent