PRINCIPAL DISPLAY PANEL - CARTON LABEL
NDC 57665-001-01

ADAGEN®
(pegademase bovine)
Injection

Four 1.5 mL single-dose vials.
250 units per mL

Sterile-For intramuscular use only.
See package insert for dosage information.
Discard if cloudy or frozen.

Store at + 2° C to + 8° C (36° F to 46° F)
REFRIGERATE-DO NOT FREEZE

Inactive Ingredients: 1.2 mg Monobasic Sodium Phosphate, 5.58 mg Dibasic Sodium Phosphate, 8.5 mg Sodium Chloride, and Water for Injection qs to 1.0 mL. Contains no preservative.
Rx Only

ENZON Pharmaceuticals, Inc.
Bridgewater, NJ 08807

 
Carton Label

ADAGEN 
pegademase bovine   injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 57665-001
Route of Administration INTRAMUSCULAR DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEGADEMASE BOVINE (PEGADEMASE BOVINE)  PEGADEMASE BOVINE 250 U  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC  
SODIUM PHOSPHATE, DIBASIC  
SODIUM CHLORIDE  
WATER  
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 57665-001-01 4 VIAL In 1 BOX contains a VIAL, SINGLE-USE
1  1.5 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (57665-001-01)
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019818 01/01/1990 10/14/2010

Labeler - Enzon Pharmaceuticals, Inc. (101686731) 
Revised: 10/2010 Enzon Pharmaceuticals, Inc.