What is NDC 15054-0080?

15054-0080 is the product NDC for Iqirvo (elafibranor), Elafibranor 80 mg/1 tablet, film coated, listed with the FDA by Ipsen Biopharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Ipsen Biopharmaceuticals, Inc., NDC labeler code 15054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Iqirvo?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Iqirvo NDC 15054-0080 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)15054-0080Labeler and product segments. Claims need a package NDC.

Product NDC at billing width15054-0080Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
15054-0080-1	1505400800115054008001	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
Labeler: Ipsen Biopharmaceuticals, Inc.NDC labeler code 15054
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 218860
Marketing start: Jun 10, 2024
Listing expires: Dec 31, 2027
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

N415054008001 followed by a unit qualifier and the quantity

Package 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 Aug 11, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 15054-0080

What is NDC 15054-0080?: 15054-0080 is the product NDC for Iqirvo (elafibranor), Elafibranor 80 mg/1 tablet, film coated, listed with the FDA by Ipsen Biopharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Iqirvo (Elafibranor).
What is the active ingredient?: Elafibranor.
Who is the labeler?: Ipsen Biopharmaceuticals, Inc., NDC labeler code 15054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Iqirvo?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Iqirvo (Elafibranor) NDC 15054-0080