NDC product
IQIRVO
NDC 15054-0080 · Ipsen Biopharmaceuticals, Inc.
Key facts
| Product NDC | 15054-0080 |
|---|---|
| Proprietary name | IQIRVO |
| Nonproprietary name | elafibranor |
| Substances | ELAFIBRANOR |
| Dosage form | TABLET, FILM COATED |
| Route | ORAL |
| Labeler | Ipsen Biopharmaceuticals, Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Application number | NDA218860 |
| Pharmacologic classes | Cytochrome P450 3A4 Inducers [MoA], Peroxisome Proliferator-activated Receptor Agonist [EPC], Peroxisome Proliferator-activated Receptor Agonists [MoA] |
| Marketing start | Jun 10, 2024 |
| Listing certified through | Dec 31, 2027 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: