FDA.reportPublic FDA data

Lifyorli

Product NDC
76346-525
11-digit product format
763460525
Labeler code
76346
Product ID
76346-525_41bf3142-d0f6-4f0c-b6da-5abe8ad3db43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Relacorilant
Dosage form
KIT
Route
ORAL
Labeler
Corcept Therapeutics Incorporated
Application
NDA220641
Marketing category
NDA
Marketing start
2026-03-25
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220641-001LIFYORLI (COPACKAGED)RELACORILANT100MG;25MGCAPSULE / ORALRLD, RS2026-03-25

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220641-001104563922033-05-24U-44572026-04-21
N220641-001115769072033-05-24U-4457Drug substance, Drug product2026-04-21
N220641-001115769072033-05-24U-4458Drug substance, Drug product2026-04-21
N220641-001115769072033-05-24U-4459Drug substance, Drug product2026-04-21
N220641-00188597742033-05-24Drug substance, Drug product2026-04-21
N220641-00192730472033-05-24U-44572026-04-21
N220641-00192730472033-05-24U-44582026-04-21
N220641-00192730472033-05-24U-44592026-04-21
N220641-001119256262039-12-18Drug product2026-04-21
N220641-001125148492039-12-18Drug product2026-04-21
N220641-001114647642040-04-14Drug product2026-04-21
N220641-001112851452041-05-26U-44572026-04-21
N220641-001112851452041-05-26U-44582026-04-21
N220641-001112851452041-05-26U-44592026-04-21
N220641-001125890942041-05-26U-44572026-04-21
N220641-001125890942041-05-26U-44582026-04-21
N220641-001125890942041-05-26U-44592026-04-21
N220641-001121520282041-12-22U-4457Drug product2026-04-21
N220641-001121520282041-12-22U-4458Drug product2026-04-21
N220641-001121520282041-12-22U-4459Drug product2026-04-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220641-001NCE2031-03-25

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001LIFYORLI (COPACKAGED)100MG;25MGCAPSULE / ORALRLD, RS2026-03-25a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001104563922033-05-24U-44572026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001115769072033-05-24U-4458Drug substance, Drug product2026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001115769072033-05-24U-4457Drug substance, Drug product2026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001115769072033-05-24U-4459Drug substance, Drug product2026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-00188597742033-05-24Drug substance, Drug product2026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-00192730472033-05-24U-44572026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-00192730472033-05-24U-44582026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-00192730472033-05-24U-44592026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001119256262039-12-18Drug product2026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001125148492039-12-18Drug product2026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001114647642040-04-14Drug product2026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001112851452041-05-26U-44582026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001112851452041-05-26U-44572026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001112851452041-05-26U-44592026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001125890942041-05-26U-44572026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001125890942041-05-26U-44582026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001125890942041-05-26U-44592026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001121520282041-12-22U-4457Drug product2026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001121520282041-12-22U-4458Drug product2026-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001121520282041-12-22U-4459Drug product2026-04-21a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220641-001NCE2031-03-25a50c72e98297…

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2739542Internal RxNorm lookup
2739548Internal RxNorm lookup
2739550Internal RxNorm lookup
2739552Internal RxNorm lookup
2739553Internal RxNorm lookup
2739554Internal RxNorm lookup
2739555Internal RxNorm lookup
2739556Internal RxNorm lookup
2739557Internal RxNorm lookup
2739558Internal RxNorm lookup
2739559Internal RxNorm lookup
2739560Internal RxNorm lookup
2739561Internal RxNorm lookup
2739562Internal RxNorm lookup
2739563Internal RxNorm lookup
2739564Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6fcebfb5-19d6-4f63-b852-999d68a13729Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76346-025-01Lifyorli1 in 1 PACKAGE, COMBINATIONCAPSULE325 mg1
76346-100-01Lifyorli1 in 1 PACKAGE, COMBINATIONCAPSULE3100 mg1
76346-525-03Lifyorli1 in 1 CARTONKIT11
76346-525-09Lifyorli3 in 1 CARTONKIT31
76346-525-33Lifyorli1 in 1 BLISTER PACKKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76346-525-03EA - Each76346-525fa8b5c68-3f17-4d63-b852-5af75042458512026-04-20
76346-525-09EA - Each76346-5252448f279-33d9-4685-85d6-936463d70ec412026-04-20
76346-525-33EA - Each76346-52599b30a9b-99c3-48e3-829c-720e7baac6ee12026-04-20

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
LifyorliRELACORILANTCorcept Therapeutics Incorporated6fcebfb5-19d6-4f63-b852-999d68a137292026-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 220641
application number: NDA220641
ndc (product): 76346-525

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739554{1 (relacorilant 100 MG Oral Capsule [Lifyorli]) / 1 (relacorilant 25 MG Oral Capsule [Lifyorli]) } Pack [Lifyorli 125 MG, 1-Dose Supply]BPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739556{1 (relacorilant 100 MG Oral Capsule [Lifyorli]) / 2 (relacorilant 25 MG Oral Capsule [Lifyorli]) } Pack [Lifyorli 150 MG, 1-Dose Supply]BPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739558{3 (relacorilant 100 MG Oral Capsule [Lifyorli]) / 3 (relacorilant 25 MG Oral Capsule [Lifyorli]) } Pack [Lifyorli 125 MG, 3-Dose Supply]BPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739562{3 (relacorilant 100 MG Oral Capsule [Lifyorli]) / 6 (relacorilant 25 MG Oral Capsule [Lifyorli]) } Pack [Lifyorli 150 MG, 3-Dose Supply]BPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739564{9 (relacorilant 100 MG Oral Capsule [Lifyorli]) / 18 (relacorilant 25 MG Oral Capsule [Lifyorli]) } Pack [Lifyorli 150 MG, 9-Dose Supply]BPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739560{9 (relacorilant 100 MG Oral Capsule [Lifyorli]) / 9 (relacorilant 25 MG Oral Capsule [Lifyorli]) } Pack [Lifyorli 125 MG, 9-Dose Supply]BPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739553{1 (relacorilant 100 MG Oral Capsule) / 1 (relacorilant 25 MG Oral Capsule) } PackGPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739555{1 (relacorilant 100 MG Oral Capsule) / 2 (relacorilant 25 MG Oral Capsule) } PackGPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739557{3 (relacorilant 100 MG Oral Capsule) / 3 (relacorilant 25 MG Oral Capsule) } PackGPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739561{3 (relacorilant 100 MG Oral Capsule) / 6 (relacorilant 25 MG Oral Capsule) } PackGPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739563{9 (relacorilant 100 MG Oral Capsule) / 18 (relacorilant 25 MG Oral Capsule) } PackGPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739559{9 (relacorilant 100 MG Oral Capsule) / 9 (relacorilant 25 MG Oral Capsule) } PackGPCK6fcebfb5-19d6-4f63-b852-999d68a137291
2739548Lifyorli 100 MG Oral CapsulePSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739554Lifyorli 125 MG, 1-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739558Lifyorli 125 MG, 3-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739560Lifyorli 125 MG, 9-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739556Lifyorli 150 MG, 1-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739562Lifyorli 150 MG, 3-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739564Lifyorli 150 MG, 9-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739552Lifyorli 25 MG Oral CapsulePSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739542relacorilant 100 MG Oral CapsulePSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739553relacorilant 125 MG, 1-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739557relacorilant 125 MG, 3-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739559relacorilant 125 MG, 9-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739555relacorilant 150 MG, 1-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739561relacorilant 150 MG, 3-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739563relacorilant 150 MG, 9-Dose PackPSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739550relacorilant 25 MG Oral CapsulePSN6fcebfb5-19d6-4f63-b852-999d68a137291
2739548relacorilant 100 MG Oral Capsule [Lifyorli]SBD6fcebfb5-19d6-4f63-b852-999d68a137291
2739552relacorilant 25 MG Oral Capsule [Lifyorli]SBD6fcebfb5-19d6-4f63-b852-999d68a137291
2739542relacorilant 100 MG Oral CapsuleSCD6fcebfb5-19d6-4f63-b852-999d68a137291
2739550relacorilant 25 MG Oral CapsuleSCD6fcebfb5-19d6-4f63-b852-999d68a137291
2739548Lifyorli 100 MG Oral CapsuleSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739554Lifyorli 125 MG, 1-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739558Lifyorli 125 MG, 3-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739560Lifyorli 125 MG, 9-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739556Lifyorli 150 MG, 1-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739562Lifyorli 150 MG, 3-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739564Lifyorli 150 MG, 9-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739552Lifyorli 25 MG Oral CapsuleSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739553relacorilant 125 MG, 1-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739557relacorilant 125 MG, 3-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739559relacorilant 125 MG, 9-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739555relacorilant 150 MG, 1-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739561relacorilant 150 MG, 3-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291
2739563relacorilant 150 MG, 9-Dose PackSY6fcebfb5-19d6-4f63-b852-999d68a137291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76346-025-01763460025011 in 1 PACKAGE, COMBINATIONHistorical
76346-100-01763460100011 in 1 PACKAGE, COMBINATIONHistorical
76346-525-03763460525031 BLISTER PACK in 1 CARTON (76346-525-03) / 1 KIT in 1 BLISTER PACK (76346-525-33) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-025-01) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-100-01) 1 blister pack2026-03-25NoNoCurrent
76346-525-09763460525093 CARTON in 1 CARTON (76346-525-09) / 1 BLISTER PACK in 1 CARTON (76346-525-03) / 1 KIT in 1 BLISTER PACK (76346-525-33) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-025-01) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-100-01) 3 carton2026-03-25NoNoCurrent
76346-525-33763460525331 in 1 BLISTER PACKHistorical