Label: METHYLPREDNISOLONE tablet

  • NDC Code(s): 70771-1348-1, 70771-1348-3, 70771-1348-5, 70771-1349-1, view more
    70771-1349-2, 70771-1349-4, 70771-1349-5, 70771-1349-8, 70771-1350-1, 70771-1350-2, 70771-1350-4, 70771-1350-5, 70771-1350-7, 70771-1351-1, 70771-1351-2, 70771-1351-4, 70771-1351-5, 70771-1351-8
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1348-1 in bottle of 100 tablets

    Methylprednisolone tablets, USP

    Ronly

    100 tablets

     

    methylprednisolone tablets

    NDC 70771-1349-8 in bottle of 25 tablets

    Methylprednisolone tablets, USP

    Ronly

    25 tablets

     

     

    methylprednisolone tablets

    NDC 70771-1350-7 in bottle of 50 tablets

    Methylprednisolone tablets, USP

    Ronly

    50 tablets

     

     

    methylprednisolone tablets

    NDC 70771-1351-8 in bottle of 25 tablets

    Methylprednisolone tablets, USP

    Ronly

    25 tablets

     

     

     

     

    methylprednisolone tablets
  • INGREDIENTS AND APPEARANCE
    METHYLPREDNISOLONE 
    methylprednisolone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1348
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score4 pieces
    ShapeOVAL (OVAL) Size8mm
    FlavorImprint Code 916
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1348-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    2NDC:70771-1348-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    3NDC:70771-1348-31 in 1 CARTON05/01/2018
    321 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20675105/01/2018
    METHYLPREDNISOLONE 
    methylprednisolone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1349
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE8 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size10mm
    FlavorImprint Code 917
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1349-825 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    2NDC:70771-1349-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    3NDC:70771-1349-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    4NDC:70771-1349-410 in 1 CARTON05/01/2018
    4NDC:70771-1349-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20675105/01/2018
    METHYLPREDNISOLONE 
    methylprednisolone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1350
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE16 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score4 pieces
    ShapeOVAL (OVAL) Size10mm
    FlavorImprint Code 918
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1350-750 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    2NDC:70771-1350-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    3NDC:70771-1350-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    4NDC:70771-1350-410 in 1 CARTON05/01/2018
    4NDC:70771-1350-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20675105/01/2018
    METHYLPREDNISOLONE 
    methylprednisolone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1351
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE32 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size14mm
    FlavorImprint Code 919
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1351-825 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    2NDC:70771-1351-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    3NDC:70771-1351-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
    4NDC:70771-1351-410 in 1 CARTON05/01/2018
    4NDC:70771-1351-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20675105/01/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1348, 70771-1349, 70771-1350, 70771-1351) , MANUFACTURE(70771-1348, 70771-1349, 70771-1350, 70771-1351)