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NDC 75987-0080-10 Krystexxa 8 mg/mL Details
Krystexxa 8 mg/mL
Krystexxa is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Horizon Therapeutics USA, Inc.. The primary component is PEGLOTICASE.
MedlinePlus Drug Summary
Pegloticase injection is used alone or in combination with methotrexate (Trexall, Xatmep) and folic acid to treat chronic gout (sudden, severe pain, redness, and swelling in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults who cannot take or did not respond to other medications. Pegloticase injection is in a class of medications called PEGylated uric acid specific enzymes. It works by decreasing the amount of uric acid in the body. Pegloticase injection is used to prevent gout attacks but not to treat them once they occur.
Related Packages: 75987-0080-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pegloticase Injection
Product Information
| NDC | 75987-0080 |
|---|---|
| Product ID | 75987-080_5cd1b348-e083-4b70-855b-eb440e5b4b57 |
| Associated GPIs | 68000050002020 |
| GCN Sequence Number | 066681 |
| GCN Sequence Number Description | pegloticase VIAL 8 MG/ML INTRAVEN |
| HIC3 | C7G |
| HIC3 Description | HYPERURICEMIA TX - URATE-OXIDASE ENZYME-TYPE |
| GCN | 29038 |
| HICL Sequence Number | 037154 |
| HICL Sequence Number Description | PEGLOTICASE |
| Brand/Generic | Brand |
| Proprietary Name | Krystexxa |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | pegloticase |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 8 |
| Active Ingredient Units | mg/mL |
| Substance Name | PEGLOTICASE |
| Labeler Name | Horizon Therapeutics USA, Inc. |
| Pharmaceutical Class | Urate Oxidase [CS], Uric Acid-specific Enzyme [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125293 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 75987-0080-10 (75987008010)
| NDC Package Code | 75987-080-10 |
|---|---|
| Billing NDC | 75987008010 |
| Package | 1 VIAL in 1 CARTON (75987-080-10) / 1 mL in 1 VIAL |
| Marketing Start Date | 2010-09-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |