Prescription drug · NDA
Livdelzi (seladelpar lysine) NDC 61958-3301
Seladelpar lysine 10 mg/1 · Capsule · Oral · Gilead Sciences, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-3301-1 | 61958330101 | 30 CAPSULE in 1 BOTTLE (61958-3301-1)Marketed from Aug 14, 2024 | |
| 61958-3301-2 | 61958330102 | 30 CAPSULE in 1 BOTTLE (61958-3301-2)Marketed from Oct 31, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Livdelzi
- Generic name (nonproprietary)
- seladelpar lysine
- Active ingredients
- Seladelpar lysine — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Gilead Sciences, Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217899
- Marketing start
- Listing expires
- Identifiers
- Product ID 61958-3301_30fbf1ef-9467-4632-99b4-9dc8e05506b5SPL ID 30fbf1ef-9467-4632-99b4-9dc8e05506b5SPL set ID 89f79d98-135c-40b2-a585-6996c04e599cRxCUI 2690875, 2690881UNII N1429130KR
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461958330101followed by a unit qualifier and the quantityPackage 61958-3301-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP) [see Clinical Studies (14) ] . Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). LIVDELZI is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for th…
Excerpt only. Read the full label for complete information.