Label: SITAGLIPTIN PHOSPHATE/METFORMIN HYDROCHLORIDE- sitagliptin and metformin hydrochloride tablet, film coated

  • NDC Code(s): 55370-006-00
  • Packager: Patheon Puerto Rico, Inc.
  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated April 29, 2016

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  • 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
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  • INGREDIENTS AND APPEARANCE
    SITAGLIPTIN PHOSPHATE/METFORMIN HYDROCHLORIDE 
    sitagliptin and metformin hydrochloride tablet, film coated
    Product Information
    Product Type BULK INGREDIENT Item Code (Source) NDC:55370-006
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z) SITAGLIPTIN PHOSPHATE 50 mg
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 850 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color pink (pink) Score no score
    Shape OVAL (capsule-shaped) Size 20mm
    Flavor Imprint Code 515
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55370-006-00 22381 in 1 CONTAINER 03/30/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 03/30/2007
    Labeler - Patheon Puerto Rico, Inc. (174050377)
    Establishment
    Name Address ID/FEI Business Operations
    Patheon Puerto Rico, Inc. 143814544 manufacture(55370-006)
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