Prescription drug · NDA
Iqirvo (elafibranor) NDC 15054-0080
Elafibranor 80 mg/1 · Tablet, Film coated · Oral · Ipsen Biopharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15054-0080-1 | 15054008001 | 1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Jun 10, 2024 |
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)
- Iqirvo
- Generic name (nonproprietary)
- elafibranor
- Active ingredients
- Elafibranor — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218860
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inducers (Mechanism)Peroxisome Proliferator-activated Receptor Agonists (Mechanism)
- Identifiers
- Product ID 15054-0080_c77d04f1-9e73-4cde-9ab3-bac12d595fc4SPL ID c77d04f1-9e73-4cde-9ab3-bac12d595fc4SPL set ID d78aa14f-6ec1-4b1d-a4ae-e48658137a25RxCUI 2684946, 2684952UNII 2J3H5C81A5
- Pharmacologic class
- Peroxisome Proliferator-activated Receptor Agonist
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
N415054008001followed by a unit qualifier and the quantityPackage 15054-0080-01. 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)
IQIRVO 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 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). IQIRVO is a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment …
Excerpt only. Read the full label for complete information.