NDC 57665-001

Adagen

Pegademase Bovine

Adagen is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Leadiant Biosciences, Inc.. The primary component is Pegademase Bovine.

• Product ID: 57665-001_b0affb48-ca3f-46a7-8260-5a4819eb21d4
• NDC: 57665-001
• Product Type: Human Prescription Drug
• Proprietary Name: Adagen
• Generic Name: Pegademase Bovine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2010-10-18
• Marketing Category: NDA / NDA
• Application Number: NDA019818
• Labeler Name: Leadiant Biosciences, Inc.
• Substance Name: PEGADEMASE BOVINE
• Active Ingredient Strength: 250 [iU]/mL
• Pharm Classes: Adenosine Deaminase [CS],Bovine Intestinal Adenosine Deaminase [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 57665-001-01

4 VIAL, SINGLE-USE in 1 BOX (57665-001-01) > 1.5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2010-10-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57665-001-01 [57665000101]

Adagen INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019818
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-10-18
• Marketing End Date: 2019-06-30

Drug Details

Active Ingredients

Ingredient	Strength
PEGADEMASE BOVINE	250 [iU]/mL

OpenFDA Data

• SPL SET ID: 9880b900-ea23-11dc-ad56-0002a5d5c51b
• Manufacturer:
  • Leadiant Biosciences, Inc.
• UNII:
  • HW3H7D91F6
• RxNorm Concept Unique ID - RxCUI:
  • 207351
  • 312249

Pharmacological Class

• Adenosine Deaminase [CS]
• Bovine Intestinal Adenosine Deaminase [EPC]