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STEGLUJAN(ertugliflozin and sitagliptin)tablets(三十五)
2018-06-21 11:17:27 来源: 作者: 【 】 浏览:19714次 评论:0
en for health professionals. 
For more information about STEGLUJAN, go to www.steglujan.com or call 1-800-622-4477. 
What are the ingredients in STEGLUJAN? 
Active ingredients: ertugliflozin and sitagliptin. 
Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, croscarmellose sodium, sodium stearyl fumarate, and magnesium stearate. 
The tablet film coating contains the following inactive ingredients: hypromellose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide/black iron oxide, and carnauba wax. 
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA 
For patent information, go to: www.merck.com/product/patent/home.html. Copyright © 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. 
usmg-mk8835a-t-1712r000 
PRINCIPAL DISPLAY PANEL - 5 mg/100 mg Tablet Bottle Label
NDC 0006-5367-03
Steglujan™
(ertugliflozin and
sitagliptin) tablets 
5 mg/100 mg 
Dispense the accompanying Medication Guide
to each patient. 
Each tablet contains 6.48 mg ertugliflozin L-pyroglutamic
acid (equivalent to 5 mg ertugliflozin) and 128.5 mg
of sitagliptin phosphate (equivalent to 100 mg sitagliptin).
Rx only 
30 Tablets 
PRINCIPAL DISPLAY PANEL - 5 mg/100 mg Tablet Bottle Label 
Close 
PRINCIPAL DISPLAY PANEL - 15 mg/100 mg Tablet Bottle Label
NDC 0006-5368-03
Steglujan™
(ertugliflozin and
sitagliptin) tablets 
15 mg/100 mg 
Dispense the accompanying Medication Guide
to each patient. 
Each tablet contains 19.43 mg ertugliflozin L-pyroglutamic
acid (equivalent to 15 mg ertugliflozin) and 128.5 mg
of sitagliptin phosphate (equivalent to 100 mg sitagliptin).
Rx only 
30 Tablets 
PRINCIPAL DISPLAY PANEL - 15 mg/100 mg Tablet Bottle Label  
INGREDIENTS AND APPEARANCE
STEGLUJAN  
ertugliflozin and sitagliptin tablet, film coated 
Product Information 
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5367 
Route of Administration ORAL 
Active Ingredient/Active Moiety 
Ingredient Name
Basis of Strength
Strength
ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP) ERTUGLIFLOZIN 5 mg 
SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z) SITAGLIPTIN 100 mg 
Inactive Ingredients 
Ingredient Name
Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)   
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)   
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)   
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)   
MAGNESIUM STEARATE (UNII: 70097M6I30)   
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)   
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)   
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)   
FERRIC OXIDE RED (UNII: 1K09F3G675) 
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