NDC 68727-800

DEFITELIO

Defibrotide Sodium

DEFITELIO is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Defibrotide Sodium.

• Product ID: 68727-800_0173efe0-e4e2-41f6-b044-81f707120906
• NDC: 68727-800
• Product Type: Human Prescription Drug
• Proprietary Name: DEFITELIO
• Generic Name: Defibrotide Sodium
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-03-30
• Marketing Category: NDA / NDA
• Application Number: NDA208114
• Labeler Name: Jazz Pharmaceuticals, Inc.
• Substance Name: DEFIBROTIDE SODIUM
• Active Ingredient Strength: 80 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 68727-800-01

2.5 mL in 1 VIAL (68727-800-01)

• Marketing Start Date: 2016-03-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68727-800-02 [68727080002]

DEFITELIO INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208114
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-03-30

NDC 68727-800-01 [68727080001]

DEFITELIO INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208114
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-03-30

Drug Details

Active Ingredients

Ingredient	Strength
DEFIBROTIDE SODIUM	80 mg/mL

OpenFDA Data

• SPL SET ID: 2c3db989-d7ad-41ed-9ebf-698dcf6c24ec
• Manufacturer:
  • Jazz Pharmaceuticals, Inc.
• UNII:
  • L7CHH2B2J0
• RxNorm Concept Unique ID - RxCUI:
  • 1746527
  • 1746532
• UPC Code:
  • 0368727800021