Label: KRISOSPB-8696- sodium phenylbutyrate granule

  • NDC Code(s): 66326-207-01, 66326-207-02, 66326-207-03, 66326-207-04, view more
    66326-207-05
  • Packager: Sri Krishna Pharmaceuticals Ltd. Unit I
  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated November 28, 2022

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  • KRISOSPB-86.96

    KRISOSPB-86.96

  • INGREDIENTS AND APPEARANCE
    KRISOSPB-8696 
    sodium phenylbutyrate granule
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:66326-207
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHENYLBUTYRATE (UNII: NT6K61736T) (PHENYLBUTYRIC ACID - UNII:7WY7YBI87E) SODIUM PHENYLBUTYRATE869.6 g  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 21.7 g  in 1 kg
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 69.6 g  in 1 kg
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) 17.4 g  in 1 kg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 21.7 g  in 1 kg
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66326-207-0225 kg in 1 DRUM12/31/2019
    2NDC:66326-207-0110 kg in 1 DRUM12/31/2019
    3NDC:66326-207-0340 kg in 1 DRUM12/31/2019
    4NDC:66326-207-0450 kg in 1 DRUM12/31/2019
    5NDC:66326-207-0575 kg in 1 DRUM12/31/2019
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/31/2019
    Labeler - Sri Krishna Pharmaceuticals Ltd. Unit I (650633472)
    Registrant - Sri Krishna Pharmaceuticals Ltd. Init I (650633472)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sri Krishna Pharmaceuticals Ltd. Unit II675981458api manufacture(66326-207)