JANUMET XR (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 50 mg/500 mg Tablet Bottle Label

NDC 0006-0078-61

Janumet® XR
(sitagliptin and metformin HCl
extended-release) tablets

50 mg/500 mg

Dispense the accompanying Medication Guide
to each patient.

Each tablet contains 64.25 mg sitagliptin phosphate
(equivalent to 50 mg sitagliptin) and 500 mgmetformin hydrochloride extended-release.

Rx only

60 Tablets

PRINCIPAL DISPLAY PANEL -- 50 mg/500 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg/1,000 mg Tablet Bottle Label

NDC 0006-0080-61

Janumet® XR
(sitagliptin and metformin HCl
extended-release) tablets

50 mg /1,000 mg

Dispense the accompanying Medication
Guide to each patient.

Each tablet contains 64.25 mg sitagliptin phosphate
(equivalent to 50 mg sitagliptin) and 1,000 mg
metformin hydrochlorideextended-release.

Rx only

60 Tablets

PRINCIPAL DISPLAY PANEL -- 50 mg/1,000 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg/1,000 mg Tablet Bottle Label

NDC 0006-0081-31

Janumet® XR
(sitagliptin and metformin HCl
extended-release) tablets

100 mg /1,000 mg

Dispense the accompanying Medication Guide
to each patient.

Each tablet contains 128.5 mg sitagliptin phosphate
(equivalent to 100 mg sitagliptin) and 1,000 mg
metformin hydrochlorideextended-release.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL -- 100 mg/1,000 mg Tablet Bottle Label
(click image for full-size original)
JANUMET XR sitagliptin and metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0078
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 500 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
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color BLUE (light blue) Score no score
Shape OVAL (bi-convex oval) Size 21mm
Flavor Imprint Code 78
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0078-61 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0006-0078-62 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0006-0078-82 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:0006-0078-28 2 BOTTLE in 1 CARTON contains a BOTTLE (0006-0078-14)
4 NDC:0006-0078-14 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (0006-0078-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202270 02/02/2012
JANUMET XR sitagliptin and metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:0006-0080-61 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0006-0080-62 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0006-0080-82 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:0006-0080-28 2 BOTTLE in 1 CARTON contains a BOTTLE (0006-0080-14)
4 NDC:0006-0080-14 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (0006-0080-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202270 02/02/2012
JANUMET XR sitagliptin and metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0081
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 100 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
Product Characteristics
Color BLUE Score no score
Shape OVAL (bi-convex oval) Size 22mm
Flavor Imprint Code 81
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0081-31 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0006-0081-54 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0006-0081-82 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:0006-0081-14 2 BOTTLE in 1 CARTON contains a BOTTLE (0006-0081-07)
4 NDC:0006-0081-07 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (0006-0081-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202270 02/02/2012
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 08/2019 Merck Sharp & Dohme Corp.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.