FABHALTA
- Product NDC
- 0078-1189
- 11-digit product format
- 000781189
- Labeler code
- 0078
- Product ID
- 0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iptacopan
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA218276
- Marketing category
- NDA
- Marketing start
- 2023-12-05
- Substance
- IPTACOPAN HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Complement Factor B Inhibitor [EPC], Complement Factor B Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0078-1189-20 | 00078118920 | 60 CAPSULE in 1 BOTTLE (0078-1189-20) | 60 capsule | 2023-12-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| FABHALTA | Novartis Pharmaceuticals Corporation | 2025-03-20 | HUMAN PRESCRIPTION DRUG LABEL | 4 |