°–86°F) [see USP Controlled Room Temperature].
Manufactured by: Patheon Italia S.p.A, Ferentino, 03013, Italy
Distributed by: Schering Corporation, a subsidiary of
Whitehouse Station, NJ 08889, USA
U.S. Patent Nos. 5,686,570; 5,747,447; and 5,756,451.
INTEGRILIN is a registered trademark of Millennium Pharmaceuticals, Inc.
Rev 03/2011
31447127T
PRINCIPAL DISPLAY PANEL - 2 mg/mL Carton
NDC 0085-1177-02
200 mg/100 mL vial for
weight-adjusted infusion
(eptifibatide) Injection
INTEGRILIN®
2 mg/mL
SINGLE USE VIAL
FOR INTRAVENOUS
USE ONLY
PRINCIPAL DISPLAY PANEL - 0.75 mg/mL Carton
NDC 0085-1136-01
75 mg/100 mL vial for
weight-adjusted infusion
(eptifibatide) Injection
INTEGRILIN®
0.75 mg/mL
SINGLE USE VIAL
FOR INTRAVENOUS
USE ONLY
Schering®
INTEGRILIN
eptifibatide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-1177
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Eptifibatide(Eptifibatide) Eptifibatide 2mg in1mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate
Sodium Hydroxide
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0085-1177-01 1VIALIn1BOX contains a VIAL
1 10mLIn1VIAL This package is contained within the BOX(0085-1177-01)
2 0085-1177-02 1VIALIn1BOX contains a VIAL
2 100mLIn1VIAL This package is contained within the BOX(0085-1177-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020718 03/30/2011
INTEGRILIN
eptifibatide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-1136
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Eptifibatide(Eptifibatide) Eptifibatide 0.75mg in1mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate
Sodium Hydroxide
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0085-1136-01 1VIALIn1BOX contains a VIAL
1 100mLIn1VIAL This package is contained within the BOX(0085-1136-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020718 03/30/2011
Labeler -Schering Corporation(001317601)
Establishment
Name Address ID/FEI Operations
Patheon Italia S.p.A. 542639765 MANUFACTURE
Establishment
Name Address ID/FEI Operations
SCHERING CORP 155914674 MANUFACTURE
|
