NDC product
FABHALTA
NDC 0078-1189 · Novartis Pharmaceuticals Corporation
Key facts
| Product NDC | 0078-1189 |
|---|---|
| Proprietary name | FABHALTA |
| Nonproprietary name | iptacopan |
| Substances | IPTACOPAN HYDROCHLORIDE |
| Dosage form | CAPSULE |
| Route | ORAL |
| Labeler | Novartis Pharmaceuticals Corporation |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Application number | NDA218276 |
| Pharmacologic classes | Complement Factor B Inhibitor [EPC], Complement Factor B Inhibitors [MoA] |
| Marketing start | Dec 5, 2023 |
| 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: