Label: RISEDRONATE SODIUM tablet, delayed release

  • NDC Code(s): 70771-1436-4
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 27, 2023

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  • MEDICATION GUIDE

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1436-4 in blister-carton of 4 (1 x 4) Unit-dose Tablets

    Risedronate Sodium Delayed-release Tablets, 35 mg

    Rx only

    4 Tablets

    Risedronate Sodium DR Tablets, 35 mg
    Risedronate Sodium DR Tablets, 35 mg
    Risedronate Sodium DR Tablets, 35 mg
  • INGREDIENTS AND APPEARANCE
    RISEDRONATE SODIUM 
    risedronate sodium tablet, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1436
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISEDRONATE SODIUM ANHYDROUS (UNII: OFG5EXG60L) (RISEDRONIC ACID - UNII:KM2Z91756Z) RISEDRONATE SODIUM ANHYDROUS35 mg
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorYELLOW (YELLOW) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 75
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1436-41 in 1 CARTON04/10/2019
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20382204/10/2019
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1436) , MANUFACTURE(70771-1436)
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