NDC 60809-801

Krystexxa

Pegloticase

Krystexxa is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Horizon Pharma Inc.. The primary component is Pegloticase.

• Product ID: 60809-801_e46925f2-7335-435e-8fe0-f4455fd01c74
• NDC: 60809-801
• Product Type: Human Prescription Drug
• Proprietary Name: Krystexxa
• Generic Name: Pegloticase
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-09-14
• Marketing Category: BLA / BLA
• Application Number: BLA125293
• Labeler Name: Horizon Pharma Inc.
• Substance Name: PEGLOTICASE
• Active Ingredient Strength: 8 mg/mL
• Pharm Classes: Urate Oxidase [CS],Uric Acid-specific Enzyme [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 60809-801-01

1 VIAL in 1 CARTON (60809-801-01) > 1 mL in 1 VIAL

• Marketing Start Date: 2010-09-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60809-801-01 [60809080101]

Krystexxa INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125293
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-09-14
• Marketing End Date: 2018-12-31

Drug Details

Active Ingredients

Ingredient	Strength
PEGLOTICASE	8 mg/mL

OpenFDA Data

• SPL SET ID: 9c0d9fbb-998c-4a62-9354-7330d64b144e
• Manufacturer:
  • Horizon Pharma Inc.
• UNII:
  • R581OT55EA
• RxNorm Concept Unique ID - RxCUI:
  • 1011653
  • 1011657

Pharmacological Class

• Urate Oxidase [CS]
• Uric Acid-specific Enzyme [EPC]

NDC Crossover Matching brand name "Krystexxa" or generic name "Pegloticase"

NDC	Brand Name	Generic Name
54396-801	Krystexxa	pegloticase
60809-801	Krystexxa	pegloticase
75987-080	Krystexxa	pegloticase