Label: COMPRESSO MF 95P powder

  • NDC Code(s): 62207-400-12, 62207-400-13, 62207-711-00, 62207-711-01, view more
    62207-711-02, 62207-711-03, 62207-711-04, 62207-711-11, 62207-711-12, 62207-711-13, 62207-711-14, 62207-711-16
  • Packager: Granules India Limited
  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated May 2, 2023

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  • SPL UNCLASSIFIED SECTION

    COMPRESSO MF 95 P

    (Directly compressible granules containing Metformin HCl USP/Ph.Eur. - 95%)

    SPECIMEN LABEL
    Batch No.:Drum No.:
    Mfg. Dt.:Tare Wt.:
    Exp. Dt.:Net Wt.:
    Mfg. Lic. No.:37/RR/AP/2003/F/RGross Wt.:
    Storage:Preserve in well closed containers. Store between 15 – 30°C
    CautionFor Manufacturing, Processing, or Repacking only.
    GIL / PL / 036Manufactured in India by:Granules India LimitedPlot No. 160/A, 161/E, Gagillapur VillageQutbullapur Mandal, Ranga Reddy Dt – 500 043, AP.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    mf-95p

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    mf96p

  • INGREDIENTS AND APPEARANCE
    COMPRESSO MF 95P 
    compresso mf 95p powder
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-711
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE95 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-711-005000000 mg in 1 BAG10/24/2013
    2NDC:62207-711-0110000000 mg in 1 BAG10/24/2013
    3NDC:62207-711-0225000000 mg in 1 BAG10/24/2013
    4NDC:62207-711-0340000000 mg in 1 BAG10/24/2013
    5NDC:62207-711-0450000000 mg in 1 BAG10/24/2013
    6NDC:62207-711-1125000000 mg in 1 BAG10/24/2013
    7NDC:62207-711-1240000000 mg in 1 BAG10/24/2013
    8NDC:62207-711-1350000000 mg in 1 BAG10/24/2013
    9NDC:62207-711-1460000000 mg in 1 BAG10/24/2013
    10NDC:62207-711-16100000000 mg in 1 BAG10/24/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only10/24/2013
    COMPRESSO MF 95P 
    compresso mf 95p powder
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-400
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE95 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-400-1240000000 mg in 1 DRUM08/17/2017
    2NDC:62207-400-1350000000 mg in 1 DRUM05/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only08/17/2017
    Labeler - Granules India Limited (915000087)
    Registrant - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236manufacture(62207-711, 62207-400) , analysis(62207-711)
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