FDA.reportPublic FDA data

WAYRILZ

Product NDC
58468-0251
11-digit product format
584680251
Labeler code
58468
Product ID
58468-0251_aa3b7d8a-0e0d-481b-bd36-4befaceba422
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rilzabrutinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Genzyme Corporation
Application
NDA219685
Marketing category
NDA
Marketing start
2025-08-29
Substance
RILZABRUTINIB
Active strength
400 mg/1
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 42.

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
N219685-001WAYRILZRILZABRUTINIB400MGTABLET / ORALRLD, RS2025-08-29

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219685-00195804272033-03-01Drug substance, Drug product2025-09-25
N219685-00189407442033-09-06U-4270Drug substance, Drug product2025-09-25
N219685-00192668952033-09-06U-4268Drug substance, Drug product2025-09-25
N219685-00199945762033-09-06U-4268Drug substance, Drug product2025-09-25
N219685-00199945762033-09-06U-4269Drug substance, Drug product2025-09-25
N219685-001121788182040-10-13U-42672025-09-25
N219685-001117083702041-02-20Drug substance2025-09-25

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219685-001NCE2030-08-29
N219685-001ODE-5522032-08-29

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
2026-08-18 06:07:402026-07N219685-001WAYRILZ400MGTABLET / ORALRLD, RS2025-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219685-001WAYRILZ400MGTABLET / ORALRLD, RS2025-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-001WAYRILZ400MGTABLET / ORALRLD, RS2025-08-2931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001WAYRILZ400MGTABLET / ORALRLD, RS2025-08-29a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N219685-00195804272033-03-01Drug substance, Drug product2025-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07N219685-00189407442033-09-06U-4270Drug substance, Drug product2025-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07N219685-00192668952033-09-06U-4268Drug substance, Drug product2025-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07N219685-00199945762033-09-06U-4268Drug substance, Drug product2025-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07N219685-00199945762033-09-06U-4269Drug substance, Drug product2025-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07N219685-001121788182040-10-13U-42672025-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07N219685-001117083702041-02-20Drug substance2025-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219685-00195804272033-03-01Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-00189407442033-09-06U-4270Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-00192668952033-09-06U-4268Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-00199945762033-09-06U-4268Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-00199945762033-09-06U-4269Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-001121788182040-10-13U-42672025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-001117083702041-02-20Drug substance2025-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00195804272033-03-01Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00189407442033-09-06U-4270Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00192668952033-09-06U-4268Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00199945762033-09-06U-4268Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00199945762033-09-06U-4269Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-001121788182040-10-13U-42672025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-001117083702041-02-20Drug substance2025-09-2531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00195804272033-03-01Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00189407442033-09-06U-4270Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00192668952033-09-06U-4268Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00199945762033-09-06U-4268Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00199945762033-09-06U-4269Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001121788182040-10-13U-42672025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001117083702041-02-20Drug substance2025-09-25a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N219685-001NCE2030-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219685-001ODE-5522032-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219685-001NCE2030-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-001NCE2030-08-2931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001NCE2030-08-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001ODE-5522032-08-29a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RILZABRUTINIB400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NWN58M4F5TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2722403Internal RxNorm lookup
2722409Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
95ffd367-9b0c-4f75-8487-5d8f3c0a5ad0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0251-0WAYRILZ28 in 1 BLISTER PACKTABLET, FILM COATED286
58468-0251-5WAYRILZ2 in 1 CARTONTABLET, FILM COATED26
58468-0251-6WAYRILZ1 in 1 CARTONTABLET, FILM COATED16
58468-0251-6WAYRILZ60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0251-6EA - Each58468-02511d871fee-a2b3-4313-863a-1d8019bf5cba12025-10-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WAYRILZRILZABRUTINIBGenzyme Corporation95ffd367-9b0c-4f75-8487-5d8f3c0a5ad02025-08-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 219685
application number: NDA219685
ndc (product): 58468-0251

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2722403rilzabrutinib 400 MG Oral TabletPSN95ffd367-9b0c-4f75-8487-5d8f3c0a5ad06
2722409WAYRILZ 400 MG Oral TabletPSN95ffd367-9b0c-4f75-8487-5d8f3c0a5ad06
2722409rilzabrutinib 400 MG Oral Tablet [Wayrilz]SBD95ffd367-9b0c-4f75-8487-5d8f3c0a5ad06
2722403rilzabrutinib 400 MG Oral TabletSCD95ffd367-9b0c-4f75-8487-5d8f3c0a5ad06
2722409Wayrilz 400 MG Oral TabletSY95ffd367-9b0c-4f75-8487-5d8f3c0a5ad06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58468-0251-05846802510028 in 1 BLISTER PACKHistorical
58468-0251-5584680251052 BLISTER PACK in 1 CARTON (58468-0251-5) / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0) 2 blister pack2025-08-29NoNoCurrent
58468-0251-6584680251061 BOTTLE in 1 CARTON (58468-0251-6) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-08-29NoNoCurrent