See accompanying circular for dosage information.

Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

7001164401
60 | No. 6749

JANUMET
sitagliptin and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0006-0575
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE(sitagliptin) sitagliptin 50mg
metformin hydrochloride(metformin) metformin hydrochloride 500mg
 
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
polyvinyl alcohol 
POVIDONE K29/32 
FERRIC OXIDE RED 
sodium lauryl sulfate 
sodium stearyl fumarate 
talc 
titanium dioxide 
 
Product Characteristics
Color PINK (light pink)  Score no score
Shape OVAL (capsule-shaped)  Size 17mm
Flavor  Imprint Code 575 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 0006-0575-82 1000TABLETIn1BOTTLE None
2 0006-0575-61 60TABLETIn1BOTTLE None
3 0006-0575-62 180TABLETIn1BOTTLE None
4 0006-0575-52 5BLISTER PACKIn1CARTON contains a BLISTER PACK(0006-0575-01)
4 0006-0575-01 10TABLETIn1BLISTER PACK This package is contained within the CARTON(0006-0575-52)
5 0006-0575-56 4POUCHIn1CARTON contains a POUCH
5  2BLISTER PACKIn1POUCH This package is contained within the CARTON(0006-0575-56) andcontains a BLISTER PACK
5  7TABLETIn1BLISTER PACK This package is contained within a POUCH and a CARTON(0006-0575-56)
6 0006-0575-60 60TABLETIn1BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022044 03/30/2007 

JANUMET
sitagliptin and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0006-0577
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE(sitagliptin) sitagliptin 50mg
metformin hydrochloride(metformin) metformin hydrochloride 1000mg
 
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
polyvinyl alcohol 
POVIDONE K29/32 
FERRIC OXIDE RED 
sodium lauryl sulfate 
sodium stearyl fumarate 
talc 
titanium dioxide 
 
Product Characteristics
Color RED (red)  Score no score
Shape OVAL (capsule-shaped)  Size 21mm
Flavor  Imprint Code 577 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 0006-0577-61 60TABLETIn1BOTTLE None
2 0006-0577-62 180TABLETIn1BOTTLE None
3 0006-0577-82 1000TABLETIn1BOTTLE None
4 0006-0577-52 5BLISTER PACKIn1CARTON contains a BLISTER PACK(0006-0