FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiN1429130KR
Rxcui2690875, 2690881

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

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