NDC 54396-801

Krystexxa

Pegloticase

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

• Product ID: 54396-801_8ec18670-b429-432f-b7c5-7a43fd397c47
• NDC: 54396-801
• 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: Savient Pharmaceuticals, 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: 2017-12-31

Packaging

NDC 54396-801-01

1 VIAL in 1 CARTON (54396-801-01) > 1 mL in 1 VIAL

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

NDC SPL Data Element Entries

NDC 54396-801-01 [54396080101]

Krystexxa INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125293
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-09-14
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
PEGLOTICASE	8 mg/mL

OpenFDA Data

• SPL SET ID: 5f4574d1-401f-4647-83e5-28c0f4a122a7
• Manufacturer:
  • Savient Pharmaceuticals, Inc.
• UNII:
  • R581OT55EA
• RxNorm Concept Unique ID - RxCUI:
  • 1011653
  • 1011657
• UPC Code:
  • 0354396801018

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