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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Krystexxa
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PEGLOTICASE | 8 mg/50mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | R581OT55EA |
| Rxcui | 1011653, 1011657, 2723378, 2723381 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75987-058-01 | Krystexxa | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 1142 | |
| 75987-058-01 | Krystexxa | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | 1142 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75987-058-01 | ML - Milliliter | 75987-058 | 482cd7c2-b244-4d3c-a7c1-f98f5fd501f5 | 1 | 2025-10-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1011657 | Krystexxa 8 MG in 1 ML Injection | PSN | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 2723381 | KRYSTEXXA 8 MG in 50 ML Injection | PSN | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 1011653 | pegloticase 8 MG in 1 ML Injection | PSN | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 2723378 | pegloticase 8 MG in 50 ML Injection | PSN | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 1011657 | 1 ML pegloticase 8 MG/ML Injection [Krystexxa] | SBD | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 2723381 | 50 ML pegloticase 0.16 MG/ML Injection [Krystexxa] | SBD | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 1011653 | 1 ML pegloticase 8 MG/ML Injection | SCD | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 2723378 | 50 ML pegloticase 0.16 MG/ML Injection | SCD | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 1011657 | Krystexxa (as uricase protein) 8 MG per 1 ML Injection | SY | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 1011657 | Krystexxa 8 MG per 1 ML Injection | SY | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 2723381 | Krystexxa 8 MG per 50 ML Injection | SY | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 1011653 | pegloticase (as uricase protein) 8 MG per 1 ML Injection | SY | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 1011653 | pegloticase 8 MG per 1 ML Injection | SY | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
| 2723378 | pegloticase 8 MG per 50 ML Injection | SY | 6e566303-d93a-4130-b764-25749829aa95 | 1143 |
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 | Current |