SITAGLIPTIN PHOSPHATE/METFORMIN HYDROCHLORIDE- sitagliptin and metformin hydrochloride tablet, film coated 
Patheon Puerto Rico, Inc.

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SITAGLIPTIN PHOSPHATE - METFORMIN HYDROCHLORIDE, TABLETS

PRINCIPAL DISPLAY PANEL - Shipping Label

SITAGLIPTIN PHOSPHATE - METFORMIN HYDROCHLORIDE,
TABLETS 50mg / 850mg

Store Conditions: Storage below 25°C

Cautions:
Health: 3
Flammability: 2
Reactivity: 2
Personal Protective Equipment: K

Manufactured by: PATHEON PUERTO RICO, INC.
STATE ROAD 670 KM 2.7
MANATI, PUERTO RICO 00674

Distributed by: MERCK & CO., INC

Lot: XXXXXXXX
Mgf. Date: MMM DD YY
Quantity: XXX Kg

Shipping Label
SITAGLIPTIN PHOSPHATE/METFORMIN HYDROCHLORIDE 
sitagliptin and metformin hydrochloride tablet, film coated
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:55370-006
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z) SITAGLIPTIN PHOSPHATE50 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE850 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONE K29/32 (UNII: 390RMW2PEQ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorpink (pink) Scoreno score
ShapeOVAL (capsule-shaped) Size20mm
FlavorImprint Code 515
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55370-006-0022381 in 1 CONTAINER03/30/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only03/30/2007
Labeler - Patheon Puerto Rico, Inc. (174050377)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Puerto Rico, Inc.143814544manufacture(55370-006)

Revised: 4/2016
Document Id: 54b46e01-d8aa-40e7-9bc6-234831f20ef2
Set id: a352f7d4-a907-4617-baac-5f165c39437b
Version: 1
Effective Time: 20160429
 
Patheon Puerto Rico, Inc.