Label: LUBIPROSTONE capsule

  • NDC Code(s): 70771-1763-1, 70771-1763-6, 70771-1764-1, 70771-1764-6
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated March 24, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1763-6

    Lubiprostone Capsules, 8 mcg

    60 Capsules

    Rx only

    8 mcg label

    NDC 70771-1764-6

    Lubiprostone Capsules, 24 mcg

    60 Capsules

    Rx only

    24 mcg label
  • INGREDIENTS AND APPEARANCE
    LUBIPROSTONE 
    lubiprostone capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1763
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LUBIPROSTONE (UNII: 7662KG2R6K) (LUBIPROSTONE - UNII:7662KG2R6K) LUBIPROSTONE8 ug
    Inactive Ingredients
    Ingredient NameStrength
    1,4-SORBITAN (UNII: AV0YTZ4E6J)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINK (light pink to pink colored) Scoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1763-660 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
    2NDC:70771-1763-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21413103/23/2023
    LUBIPROSTONE 
    lubiprostone capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1764
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LUBIPROSTONE (UNII: 7662KG2R6K) (LUBIPROSTONE - UNII:7662KG2R6K) LUBIPROSTONE24 ug
    Inactive Ingredients
    Ingredient NameStrength
    1,4-SORBITAN (UNII: AV0YTZ4E6J)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOW (light yellow colored) Scoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1764-660 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
    2NDC:70771-1764-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21413103/23/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1763, 70771-1764) , MANUFACTURE(70771-1763, 70771-1764)