Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Marketed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
and
Eli Lilly and Company
Indianapolis, IN 46285 USA

Licensed from:
Boehringer Ingelheim International GmbH
Ingelheim, Germany

*The brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc., or its products.

Copyright 2011 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

IT5253AD2911
10007261/01

IT5437AD2911
10007237/01

Revised May 2011
TRADJENTA (linagliptin) 30 Tablets
NDC: 0597-0140-30

TRADJENTA (linagliptin) 1000 Tablets
NDC: 0597-0140-10

TRADJENTA (linagliptin) 7 Tablets
v NDC: 0597-0140-70

TRADJENTA (linagliptin) 90 Tablets
NDC: 0597-0140-90

TRADJENTA 
linagliptin   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0597-0140
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
linagliptin (linagliptin)  linagliptin 5 mg
 
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
STARCH, CORN  
COPOVIDONE  
MAGNESIUM STEARATE  
HYPROMELLOSE 2910 (5 MPA.S)  
TITANIUM DIOXIDE  
TALC  
POLYETHYLENE GLYCOL 6000  
FERRIC OXIDE RED  
 
Product Characteristics
Color RED (Light Red)  Score no score 
Shape ROUND Size 8mm
Flavor  Imprint Code D5; 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0597-0140-30 30  In 1 BOTTLE None
2 0597-0140-90 90  In 1 BOTTLE None
3 0597-0140-10 1000  In 1 BOTTLE None
4 0597-0140-70 1  In 1 CARTON contains a BLISTER PACK
4  7  In 1 BLISTER PACK This package is contained within the CARTON (0597-0140-70)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201280 05/09/2011 

Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944) 
Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Pharma GmbH & Co. KG  551147440 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Roxane Inc.  058839929 MANUFACTURE
Revised: 05/2011Boehringer Ingelheim Pharmaceuticals, Inc.