Label: SEVELAMER CARBONATE tablet, film coated

  • NDC Code(s): 70771-1520-0, 70771-1520-2, 70771-1520-4, 70771-1520-8
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 13, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1520-8

    Sevelamer Tablets, 800 mg

    270  Tablets

    Rx only

    label
  • INGREDIENTS AND APPEARANCE
    SEVELAMER CARBONATE 
    sevelamer carbonate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SEVELAMER CARBONATE (UNII: 9YCX42I8IU) (SEVELAMER - UNII:941N5DUU5C) SEVELAMER CARBONATE800 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (off-white to pale yellow) Scoreno score
    ShapeCAPSULE (MODIFIED CAPSULE) Size20mm
    FlavorImprint Code 824
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1520-8270 in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
    2NDC:70771-1520-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
    3NDC:70771-1520-410 in 1 CARTON09/17/2020
    3NDC:70771-1520-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20775909/17/2020
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (863362789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1520) , MANUFACTURE(70771-1520)