Label: OXYBUTYNIN tablet, film coated, extended release

  • NDC Code(s): 70771-1086-1, 70771-1086-2, 70771-1086-3, 70771-1086-4, view more
    70771-1086-5, 70771-1086-6, 70771-1086-9, 70771-1087-1, 70771-1087-2, 70771-1087-3, 70771-1087-4, 70771-1087-5, 70771-1087-6, 70771-1087-9, 70771-1088-1, 70771-1088-2, 70771-1088-3, 70771-1088-4, 70771-1088-5, 70771-1088-6, 70771-1088-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Oxybutynin chloride extended-release tablets USP, 5 mg

    NDC 70771-1086-3

    30 tablets

    Rx   only

    Oxybutynin chloride extended-release tablets

    Oxybutynin chloride extended-release tablets USP, 10 mg

    NDC 70771-1087-3

    30 tablets

    Rx   only

    Oxybutynin chloride extended-release tablets

    Oxybutynin chloride extended-release tablets USP, 15 mg

    NDC 70771-1088-3

    30 tablets

    Rx   only

    Oxybutynin chloride extended-release tablets
  • INGREDIENTS AND APPEARANCE
    OXYBUTYNIN 
    oxybutynin tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1086
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 255
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1086-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    2NDC:70771-1086-660 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    3NDC:70771-1086-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    4NDC:70771-1086-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    5NDC:70771-1086-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    6NDC:70771-1086-410 in 1 CARTON08/10/2017
    6NDC:70771-1086-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20233208/10/2017
    OXYBUTYNIN 
    oxybutynin tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1087
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 256
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1087-660 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    2NDC:70771-1087-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    3NDC:70771-1087-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    4NDC:70771-1087-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    5NDC:70771-1087-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    6NDC:70771-1087-410 in 1 CARTON08/10/2017
    6NDC:70771-1087-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20233208/10/2017
    OXYBUTYNIN 
    oxybutynin tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1088
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 257
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1088-660 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    2NDC:70771-1088-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    3NDC:70771-1088-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    4NDC:70771-1088-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    5NDC:70771-1088-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    6NDC:70771-1088-410 in 1 CARTON08/10/2017
    6NDC:70771-1088-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20233208/10/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1086, 70771-1087, 70771-1088) , MANUFACTURE(70771-1086, 70771-1087, 70771-1088)