JANUMET XR (Page 8 of 8)

sitagliptin and metformin hydrochloride

Label ImageLabel Image
JANUMET XR sitagliptin and metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4411(NDC:0006-0080)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 50 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 1000 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
HYPROMELLOSE 2208 (100000 MPA.S)
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
PROPYL GALLATE
POLYETHYLENE GLYCOL 3350
KAOLIN
HYPROMELLOSE 2910 (6 MPA.S)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
TITANIUM DIOXIDE
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
ALUMINUM OXIDE
CARNAUBA WAX
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN (light green) Score no score
Shape OVAL (bi-convex oval) Size 22mm
Flavor Imprint Code 80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4411-0 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:50090-4411-1 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202270 02/02/2012
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4411), REPACK (50090-4411)

Revised: 02/2021 A-S Medication Solutions

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