Label: ALBUTEROL tablet

  • NDC Code(s): 70771-1511-1, 70771-1512-1, 70771-1512-5
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 23, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1511-1 in bottle of 100 tablets

    Albuterol tablets USP, 2 mg

    Rx only

    100 Tablets

    label

    NDC 70771-1512-1 in bottle of 100 tablets

    Albuterol tablets USP, 4 mg

    Rx only

    100 Tablets

    label
  • INGREDIENTS AND APPEARANCE
    ALBUTEROL 
    albuterol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1511
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL2 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (white to off-white) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code 10;61
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1511-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20888410/23/2020
    ALBUTEROL 
    albuterol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1512
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL4 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 10;62
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1512-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/23/2020
    2NDC:70771-1512-5500 in 1 BOTTLE; Type 0: Not a Combination Product10/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20888410/23/2020
    Labeler - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1511, 70771-1512) , MANUFACTURE(70771-1511, 70771-1512)