Home NDC 61958-3301 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217899-001 LIVDELZI SELADELPAR LYSINE EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217899-001 7301050 2027-08-02 Drug substance, Drug product 2024-08-30 N217899-001 7709682 2027-09-13 Drug substance 2024-08-30 N217899-001 10272058 2035-03-19 U-1854 2024-08-30 N217899-001 11406611 2035-03-19 U-1854 2024-08-30 N217899-001 11596614 2035-03-19 U-1854 2024-08-30 N217899-001 9486428 2035-03-19 U-1854 2024-08-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217899-001 NCE 2029-08-14 N217899-001 ODE-486 2031-08-14
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217899-001 LIVDELZI EQ 10MG BASE CAPSULE / ORAL RLD, RS 2024-08-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 78 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N217899-001 7301050 2027-08-02 Drug substance, Drug product 2024-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217899-001 7709682 2027-09-13 Drug substance 2024-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217899-001 10272058 2035-03-19 U-1854 2024-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217899-001 11406611 2035-03-19 U-1854 2024-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217899-001 11596614 2035-03-19 U-1854 2024-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217899-001 9486428 2035-03-19 U-1854 2024-08-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217899-001 7301050 2026-08-02 Drug substance, Drug product 2024-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217899-001 7709682 2026-09-13 Drug substance 2024-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217899-001 10272058 2035-03-19 U-1854 2024-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217899-001 11406611 2035-03-19 U-1854 2024-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217899-001 11596614 2035-03-19 U-1854 2024-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217899-001 9486428 2035-03-19 U-1854 2024-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217899-001 7301050 2026-08-02 Drug substance, Drug product 2024-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217899-001 7709682 2026-09-13 Drug substance 2024-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217899-001 10272058 2035-03-19 U-1854 2024-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217899-001 11406611 2035-03-19 U-1854 2024-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217899-001 11596614 2035-03-19 U-1854 2024-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217899-001 9486428 2035-03-19 U-1854 2024-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217899-001 7301050 2026-08-02 Drug substance, Drug product 2024-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217899-001 7709682 2026-09-13 Drug substance 2024-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217899-001 10272058 2035-03-19 U-1854 2024-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217899-001 11406611 2035-03-19 U-1854 2024-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217899-001 11596614 2035-03-19 U-1854 2024-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217899-001 9486428 2035-03-19 U-1854 2024-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217899-001 7301050 2025-08-02 Drug substance, Drug product 2024-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217899-001 7709682 2026-09-13 Drug substance 2024-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217899-001 10272058 2035-03-19 U-1854 2024-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217899-001 11406611 2035-03-19 U-1854 2024-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217899-001 11596614 2035-03-19 U-1854 2024-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217899-001 9486428 2035-03-19 U-1854 2024-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217899-001 7301050 2025-08-02 Drug substance, Drug product 2024-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217899-001 7709682 2026-09-13 Drug substance 2024-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217899-001 10272058 2035-03-19 U-1854 2024-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217899-001 11406611 2035-03-19 U-1854 2024-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217899-001 11596614 2035-03-19 U-1854 2024-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217899-001 9486428 2035-03-19 U-1854 2024-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217899-001 7301050 2025-08-02 Drug substance, Drug product 2024-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217899-001 7709682 2026-09-13 Drug substance 2024-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217899-001 10272058 2035-03-19 U-1854 2024-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217899-001 11406611 2035-03-19 U-1854 2024-08-30 b8a1b40f171c…
Observed Orange Book exclusivity history# 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 Ingredient Strength SELADELPAR LYSINE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N1429130KR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2690875 Internal RxNorm lookup 2690881 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61958-3301-1 Livdelzi 30 in 1 BOTTLE CAPSULE 30 3 61958-3301-2 Livdelzi 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-3301 LIVDELZI (SELADELPAR LYSINE) CAPSULE [GILEAD SCIENCES, INC] 1 Current NDC, 2 package rows 20240816_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 61958-3301-1 61958330101 30 CAPSULE in 1 BOTTLE (61958-3301-1) 30 capsule 2024-08-14 No No Current 61958-3301-2 61958330102 30 CAPSULE in 1 BOTTLE (61958-3301-2) 30 capsule 2025-10-31 No No Current