GAMIFANT
- Product NDC
- 66658-524
- 11-digit product format
- 666580524
- Labeler code
- 66658
- Product ID
- 66658-524_58d52c0a-08fe-40f4-86ba-752dd079ec91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emapalumab-lzsg
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Swedish Orphan Biovitrum AB (publ)
- Application
- BLA761107
- Marketing category
- BLA
- Marketing start
- 2023-06-07
- Substance
- EMAPALUMAB
- Active strength
- 250 mg/10mL
- Pharmacologic classes
- Interferon gamma Antagonists [MoA], Interferon gamma Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 3S252O2Z4X | EMAPALUMAB | 1709815-23-5 | EMAPALUMAB |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 66658-524-01 | 66658052401 | 1 VIAL, SINGLE-USE in 1 CARTON (66658-524-01) / 10 mL in 1 VIAL, SINGLE-USE | 2023-06-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| GAMIFANT | Swedish Orphan Biovitrum AB (publ) | 2026-03-26 | HUMAN PRESCRIPTION DRUG LABEL | 10 |