Krystexxa
- Product NDC
- 75987-058
- 11-digit product format
- 759870058
- Labeler code
- 75987
- Product ID
- 75987-058_0391b7f8-de21-41a5-b125-aace02db52b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegloticase
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Horizon Therapeutics USA, Inc.
- Application
- BLA125293
- Marketing category
- BLA
- Marketing start
- 2025-08-29
- Substance
- PEGLOTICASE
- Active strength
- 8 mg/50mL
- Pharmacologic classes
- Urate Oxidase [CS], Uric Acid-specific Enzyme [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 |
|---|
| R581OT55EA | PEGLOTICASE | 885051-90-1 | PEGLOTICASE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 75987-058-01 | 75987005801 | 1 VIAL in 1 CARTON (75987-058-01) / 50 mL in 1 VIAL | 1 vial | 2025-08-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Krystexxa | Horizon Therapeutics USA, Inc. | Amgen, Inc | 2026-04-26 | HUMAN PRESCRIPTION DRUG LABEL | 1142 |