ARGATROBAN- argatroban injection, solution 
Glaxo Operations UK Ltd

----------

Principal Display Panel

NDC 0007-4407-01

ARGATROBAN

INJECTION

250 mg / 2.5 mL

Each mL contains 100 mg Argatroban

Rx only

For I.V. Infusion Only

Dilute Prior to Use

Each 2.5 mL contains 250 mg Argatroban, 750 mg D-sorbitol and 1000 mg dehydrated alcohol. Contains no preservative.

Store at 25oC (77oF); excursions permitted to 15o – 30oC (59o – 86oF). DO NOT FREEZE.

Manufactured, Distributed and Marketed by GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Japan

10000000106981 Rev. 6/12

Argatroban Injection 250mg per 2.5mL label
ARGATROBAN 
argatroban injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-010
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARGATROBAN (UNII: IY90U61Z3S) (ARGATROBAN ANHYDROUS - UNII:OCY3U280Y3) ARGATROBAN100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
ColorYELLOW (clear, colorless to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-010-001 in 1 CARTON11/28/2000
12.5 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:63379-010-011 in 1 CARTON11/28/2000
22.5 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02088311/28/2000
Labeler - Glaxo Operations UK Ltd (424738227)

Revised: 11/2017
Document Id: dddc8cef-b6a3-463c-a4eb-b81f657e03aa
Set id: 4fc6b940-9481-49e5-9c45-d3873fda9dba
Version: 3
Effective Time: 20171129
 
Glaxo Operations UK Ltd