Livdelzi

Product NDC
61958-3301
11-digit product format
619583301
Labeler code
61958
Product ID
61958-3301_30fbf1ef-9467-4632-99b4-9dc8e05506b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SELADELPAR LYSINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Gilead Sciences, Inc
Application
NDA217899
Marketing category
NDA
Marketing start
2024-08-14
Substance
SELADELPAR LYSINE
Active strength
10 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
N217899-001LIVDELZISELADELPAR LYSINEEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-14

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217899-00173010502027-08-02Drug substance, Drug product2024-08-30
N217899-00177096822027-09-13Drug substance2024-08-30
N217899-001102720582035-03-19U-18542024-08-30
N217899-001114066112035-03-19U-18542024-08-30
N217899-001115966142035-03-19U-18542024-08-30
N217899-00194864282035-03-19U-18542024-08-30

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217899-001NCE2029-08-14
N217899-001ODE-4862031-08-14

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 22:38:342026-08N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-1484e616aacf4f…
2026-08-18 06:07:402026-07N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-14d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217899-001LIVDELZIEQ 10MG BASECAPSULE / ORALRLD, RS2024-08-14a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217899-00173010502027-08-02Drug substance, Drug product2024-08-3084e616aacf4f…
2026-09-14 22:38:342026-08N217899-00177096822027-09-13Drug substance2024-08-3084e616aacf4f…
2026-09-14 22:38:342026-08N217899-001102720582035-03-19U-18542024-08-3084e616aacf4f…
2026-09-14 22:38:342026-08N217899-001114066112035-03-19U-18542024-08-3084e616aacf4f…
2026-09-14 22:38:342026-08N217899-001115966142035-03-19U-18542024-08-3084e616aacf4f…
2026-09-14 22:38:342026-08N217899-00194864282035-03-19U-18542024-08-3084e616aacf4f…
2026-08-18 06:07:402026-07N217899-00173010502026-08-02Drug substance, Drug product2024-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N217899-00177096822026-09-13Drug substance2024-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N217899-001102720582035-03-19U-18542024-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N217899-001114066112035-03-19U-18542024-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N217899-001115966142035-03-19U-18542024-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N217899-00194864282035-03-19U-18542024-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217899-00173010502026-08-02Drug substance, Drug product2024-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217899-00177096822026-09-13Drug substance2024-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217899-001102720582035-03-19U-18542024-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217899-001114066112035-03-19U-18542024-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217899-001115966142035-03-19U-18542024-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217899-00194864282035-03-19U-18542024-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217899-00173010502026-08-02Drug substance, Drug product2024-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217899-00177096822026-09-13Drug substance2024-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217899-001102720582035-03-19U-18542024-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217899-001114066112035-03-19U-18542024-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217899-001115966142035-03-19U-18542024-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217899-00194864282035-03-19U-18542024-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N217899-00173010502025-08-02Drug substance, Drug product2024-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217899-00177096822026-09-13Drug substance2024-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217899-001102720582035-03-19U-18542024-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217899-001114066112035-03-19U-18542024-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217899-001115966142035-03-19U-18542024-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217899-00194864282035-03-19U-18542024-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217899-00173010502025-08-02Drug substance, Drug product2024-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217899-00177096822026-09-13Drug substance2024-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217899-001102720582035-03-19U-18542024-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217899-001114066112035-03-19U-18542024-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217899-001115966142035-03-19U-18542024-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217899-00194864282035-03-19U-18542024-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217899-00173010502025-08-02Drug substance, Drug product2024-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217899-00177096822026-09-13Drug substance2024-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217899-001102720582035-03-19U-18542024-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217899-001114066112035-03-19U-18542024-08-30b8a1b40f171c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N217899-001NCE2029-08-1484e616aacf4f…
2026-09-14 22:38:342026-08N217899-001ODE-4862031-08-1484e616aacf4f…
2026-08-18 06:07:402026-07N217899-001NCE2029-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N217899-001ODE-4862031-08-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217899-001NCE2029-08-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217899-001ODE-4862031-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217899-001NCE2029-08-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217899-001ODE-4862031-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217899-001NCE2029-08-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217899-001ODE-4862031-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217899-001NCE2029-08-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217899-001ODE-4862031-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217899-001NCE2029-08-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217899-001ODE-4862031-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217899-001NCE2029-08-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217899-001ODE-4862031-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217899-001NCE2029-08-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217899-001ODE-4862031-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217899-001NCE2029-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217899-001NCE2029-08-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217899-001ODE-4862031-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217899-001NCE2029-08-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N217899-001ODE-4862031-08-14d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217899-001NCE2029-08-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217899-001ODE-4862031-08-14a50c72e98297…

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
Livdelzi
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELADELPAR LYSINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N1429130KRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2690875Internal RxNorm lookup
2690881Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89f79d98-135c-40b2-a585-6996c04e599cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7d503c8f-e46a-4695-bae6-7820fdc97e85Product name120250317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-3301-1Livdelzi30 in 1 BOTTLECAPSULE303
61958-3301-2Livdelzi30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-3301-1EA - Each61958-3301eae165e7-31a4-4d55-9d0e-e3e36b5a0ba612024-09-09
61958-3301-2EA - Each61958-3301575b13d4-b353-4c70-b0e4-8bce3b2aad3012025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-3301LIVDELZI (SELADELPAR LYSINE) CAPSULE [GILEAD SCIENCES, INC]1Current NDC, 2 package rows20240816_89f79d98-135c-40b2-a585-6996c04e599c.zip

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
LivdelziSELADELPAR LYSINEGilead Sciences, Inc89f79d98-135c-40b2-a585-6996c04e599c2026-02-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 217899
application number: NDA217899
ndc (product): 61958-3301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2690881Livdelzi 10 MG Oral CapsulePSN89f79d98-135c-40b2-a585-6996c04e599c3
2690875seladelpar 10 MG Oral CapsulePSN89f79d98-135c-40b2-a585-6996c04e599c3
2690881seladelpar 10 MG Oral Capsule [Livdelzi]SBD89f79d98-135c-40b2-a585-6996c04e599c3
2690875seladelpar 10 MG Oral CapsuleSCD89f79d98-135c-40b2-a585-6996c04e599c3
2690881Livdelzi 10 MG (equivalent to 14.1 MG seladelpar lysine) Oral CapsuleSY89f79d98-135c-40b2-a585-6996c04e599c3
2690875seladelpar 10 MG (equivalent to 14.1 MG seladelpar lysine) Oral CapsuleSY89f79d98-135c-40b2-a585-6996c04e599c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61958-3301-16195833010130 CAPSULE in 1 BOTTLE (61958-3301-1) 30 capsule2024-08-14NoNoCurrent
61958-3301-26195833010230 CAPSULE in 1 BOTTLE (61958-3301-2) 30 capsule2025-10-31NoNoCurrent