Label: BENZONATATE capsule

  • NDC Code(s): 65841-614-01, 65841-614-05, 65841-843-01
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 6, 2021

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-614-01 in bottle of 100 capsules

    Benzonatate Capsules USP, 100 mg

    Rx only

    100 capsules

    Benzonatate Capsules

    NDC 65841-843-01 in bottle of 100 capsules

    Benzonatate Capsules USP, 200 mg

    Rx only

    100 capsules

    Benzonatate Capsules
  • INGREDIENTS AND APPEARANCE
    BENZONATATE 
    benzonatate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-614
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW) Scoreno score
    ShapeROUND (ROUND) Size3mm
    FlavorImprint Code Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-614-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2007
    2NDC:65841-614-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04059709/04/2007
    BENZONATATE 
    benzonatate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-843
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW) Scoreno score
    ShapeOVAL (Oval) Size6mm
    FlavorImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-843-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04059709/04/2007
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-614, 65841-843) , MANUFACTURE(65841-614, 65841-843)