Label: BUSPIRONE HYDROCHLORIDE tablet

  • NDC Code(s): 65841-781-01, 65841-781-05, 65841-781-10, 65841-781-30, view more
    65841-781-77, 65841-782-01, 65841-782-05, 65841-782-10, 65841-782-30, 65841-782-77, 65841-783-01, 65841-783-05, 65841-783-10, 65841-783-14, 65841-783-28, 65841-783-30, 65841-783-77, 65841-784-10, 65841-784-14, 65841-784-30, 65841-784-77
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 24, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-781-01 in bottle of 100 tablets

    Buspirone Hydrochloride Tablets USP, 5 mg

    Rx only

    100 tablets

    Buspirone Hydrochloride Tablets USP, 5 mg

    NDC 65841-782-01 in bottle of 100 tablets

    Buspirone Hydrochloride Tablets USP, 10 mg

    Rx only

    100 tablets

    Buspirone Hydrochloride Tablets USP, 10 mg

    NDC 65841-783-01 in bottle of 100 tablets

    Buspirone Hydrochloride Tablets USP, 15 mg

    Rx only

    100 tablets

    Buspirone Hydrochloride Tablets USP, 15 mg

    NDC 65841-784-14 in bottle of 60 tablets

    Buspirone Hydrochloride Tablets USP, 30 mg

    Rx only

    60 tablets

    Buspirone Hydrochloride Tablets USP, 30 mg
  • INGREDIENTS AND APPEARANCE
    BUSPIRONE HYDROCHLORIDE 
    buspirone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-781
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL) BUSPIRONE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Score2 pieces
    ShapeCAPSULE (CAPSULE) Size8mm
    FlavorImprint Code ZE;36
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-781-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    2NDC:65841-781-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    3NDC:65841-781-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    4NDC:65841-781-77100 in 1 CARTON05/03/2014
    4NDC:65841-781-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07888805/03/2014
    BUSPIRONE HYDROCHLORIDE 
    buspirone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-782
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL) BUSPIRONE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Score2 pieces
    ShapeCAPSULE (CAPSULE) Size10mm
    FlavorImprint Code ZE;37
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-782-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    2NDC:65841-782-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    3NDC:65841-782-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    4NDC:65841-782-77100 in 1 CARTON05/03/2014
    4NDC:65841-782-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07888805/03/2014
    BUSPIRONE HYDROCHLORIDE 
    buspirone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-783
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL) BUSPIRONE HYDROCHLORIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Score3 pieces
    ShapeCAPSULE (CAPSULE) Size12mm
    FlavorImprint Code 5;ZE;38
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-783-1460 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    2NDC:65841-783-28180 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    3NDC:65841-783-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    4NDC:65841-783-77100 in 1 CARTON05/03/2014
    4NDC:65841-783-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:65841-783-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    6NDC:65841-783-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07888805/03/2014
    BUSPIRONE HYDROCHLORIDE 
    buspirone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-784
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL) BUSPIRONE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Score3 pieces
    ShapeCAPSULE (CAPSULE) Size17mm
    FlavorImprint Code 10;ZE;39
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-784-1460 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    2NDC:65841-784-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2014
    3NDC:65841-784-77100 in 1 CARTON05/03/2014
    3NDC:65841-784-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07888805/03/2014
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-781, 65841-782, 65841-783, 65841-784) , MANUFACTURE(65841-781, 65841-782, 65841-783, 65841-784)