FDA.reportPublic FDA data

LYNKUET

Product NDC
50419-475
Requested package NDC
50419-475-73
11-digit product format
504190475
Labeler code
50419
Product ID
50419-475_35894d94-556e-4bb6-ada9-9d63788de46a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
elinzanetant
Dosage form
CAPSULE
Route
ORAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA219469
Marketing category
NDA
Marketing start
2025-10-24
Substance
ELINZANETANT
Active strength
60 mg/1
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 43.

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
N219469-001LYNKUETELINZANETANT60MGCAPSULE / ORALRLD, RS2025-10-24

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219469-00176830562027-09-15Drug substance, Drug product2025-11-13
N219469-001101952052036-05-18U-36222025-11-13
N219469-001107740912039-03-13Drug product2025-11-13
N219469-001117878202039-03-13U-36222025-11-13
N219469-001122641642039-03-13U-36222025-11-13
N219469-001125333582045-05-14U-44022026-02-09

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219469-001NCE2030-10-24

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
2026-09-14 22:38:342026-08N219469-001LYNKUET60MGCAPSULE / ORALRLD, RS2025-10-2484e616aacf4f…
2026-08-18 06:07:402026-07N219469-001LYNKUET60MGCAPSULE / ORALRLD, RS2025-10-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219469-001LYNKUET60MGCAPSULE / ORALRLD, RS2025-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219469-001LYNKUET60MGCAPSULE / ORALRLD, RS2025-10-2431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219469-001LYNKUET60MGCAPSULE / ORALRLD, RS2025-10-24a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219469-00176830562027-09-15Drug substance, Drug product2025-11-1384e616aacf4f…
2026-09-14 22:38:342026-08N219469-001101952052036-05-18U-36222025-11-1384e616aacf4f…
2026-09-14 22:38:342026-08N219469-001107740912039-03-13Drug product2025-11-1384e616aacf4f…
2026-09-14 22:38:342026-08N219469-001117878202039-03-13U-36222025-11-1384e616aacf4f…
2026-09-14 22:38:342026-08N219469-001122641642039-03-13U-36222025-11-1384e616aacf4f…
2026-09-14 22:38:342026-08N219469-001125333582045-05-14U-44022026-02-0984e616aacf4f…
2026-08-18 06:07:402026-07N219469-00176830562027-09-15Drug substance, Drug product2025-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N219469-001101952052036-05-18U-36222025-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N219469-001107740912039-03-13Drug product2025-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N219469-001117878202039-03-13U-36222025-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N219469-001122641642039-03-13U-36222025-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N219469-001125333582045-05-14U-44022026-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219469-00176830562026-09-15Drug substance, Drug product2025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219469-001101952052036-05-18U-36222025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219469-001107740912039-03-13Drug product2025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219469-001117878202039-03-13U-36222025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219469-001122641642039-03-13U-36222025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219469-001125333582045-05-14U-44022026-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219469-00176830562026-09-15Drug substance, Drug product2025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219469-001101952052036-05-18U-36222025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219469-001107740912039-03-13Drug product2025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219469-001117878202039-03-13U-36222025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219469-001122641642039-03-13U-36222025-11-1331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219469-00176830562027-09-15Drug substance, Drug product2025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219469-001101952052036-05-18U-36222025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219469-001107740912039-03-13Drug product2025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219469-001117878202039-03-13U-36222025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219469-001122641642039-03-13U-36222025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219469-001125333582045-05-14U-44022026-02-09a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219469-001NCE2030-10-2484e616aacf4f…
2026-08-18 06:07:402026-07N219469-001NCE2030-10-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219469-001NCE2030-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219469-001NCE2030-10-2431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219469-001NCE2030-10-24a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
LYNKUET
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELINZANETANT60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NZW2BOW35NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2725516Internal RxNorm lookup
2725522Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f42884ff-7dff-419c-8a0c-affe2ed73818Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-475-01LYNKUET12 in 1 BLISTER PACKCAPSULE129
50419-475-05LYNKUET5 in 1 CARTONCAPSULE59
50419-475-71LYNKUET12 in 1 BLISTER PACKCAPSULE129
50419-475-72LYNKUET2 in 1 CARTONCAPSULE29
50419-475-73LYNKUET1 in 1 CARTONCAPSULE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-475-01EA - Each50419-475727a1796-e45c-4566-a387-fdf941e73f7612025-12-16
50419-475-05EA - Each50419-4752b19d65b-d085-4c57-beb1-cbacedc8843012025-11-13

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
LYNKUETELINZANETANTBayer HealthCare Pharmaceuticals Inc.f42884ff-7dff-419c-8a0c-affe2ed738182026-06-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 219469
application number: NDA219469
ndc (package): 50419-475-73
ndc (product): 50419-475
ndc11 (package): 50419047573

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725516elinzanetant 60 MG Oral CapsulePSNf42884ff-7dff-419c-8a0c-affe2ed738189
2725522Lynkuet 60 MG Oral CapsulePSNf42884ff-7dff-419c-8a0c-affe2ed738189
2725522elinzanetant 60 MG Oral Capsule [Lynkuet]SBDf42884ff-7dff-419c-8a0c-affe2ed738189
2725516elinzanetant 60 MG Oral CapsuleSCDf42884ff-7dff-419c-8a0c-affe2ed738189
2725522Lynkuet 60 MG Oral CapsuleSYf42884ff-7dff-419c-8a0c-affe2ed738189

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50419-475-73504190475731 BLISTER PACK in 1 CARTON (50419-475-73) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71) 1 blister pack2026-05-07NoNoCurrent