Label: ETODOLAC tablet, film coated, extended release

  • NDC Code(s): 65841-777-01, 65841-777-05, 65841-777-10, 65841-777-14, view more
    65841-777-30, 65841-777-77, 65841-778-01, 65841-778-05, 65841-778-10, 65841-778-14, 65841-778-30, 65841-778-77, 65841-779-01, 65841-779-05, 65841-779-10, 65841-779-14, 65841-779-30, 65841-779-77
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 26, 2023

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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-777-14 in bottle of 60 tablets

    Etodolac Extended-release Tablets USP, 400 mg

    Rx only

    60 tablets

    Etodolac Extended-release Tablets USP, 400 mg

    NDC 65841-778-14 in bottle of 60 tablets

    Etodolac Extended-release Tablets USP, 500 mg

    Rx only

    60 tablets

    Etodolac Extended-release Tablets USP, 500 mg

    NDC 65841-779-14 in bottle of 60 tablets

    Etodolac Extended-release Tablets USP, 600 mg

    Rx only

    60 tablets

    Etodolac Extended-release Tablets USP, 600 mg
  • INGREDIENTS AND APPEARANCE
    ETODOLAC 
    etodolac tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-777
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008) ETODOLAC400 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Product Characteristics
    ColorORANGE (ORANGE) Scoreno score
    ShapeOVAL (OVAL) Size17mm
    FlavorImprint Code 271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-777-1460 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    2NDC:65841-777-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    3NDC:65841-777-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    4NDC:65841-777-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    5NDC:65841-777-77100 in 1 CARTON02/15/2014
    5NDC:65841-777-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09113402/15/2014
    ETODOLAC 
    etodolac tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-778
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008) ETODOLAC500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Product Characteristics
    ColorGRAY (GRAY) Scoreno score
    ShapeOVAL (OVAL) Size18mm
    FlavorImprint Code 272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-778-1460 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    2NDC:65841-778-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    3NDC:65841-778-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    4NDC:65841-778-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    5NDC:65841-778-77100 in 1 CARTON02/15/2014
    5NDC:65841-778-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09113402/15/2014
    ETODOLAC 
    etodolac tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-779
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008) ETODOLAC600 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Product Characteristics
    ColorBLUE (BLUE) Scoreno score
    ShapeOVAL (OVAL) Size19mm
    FlavorImprint Code 273
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-779-1460 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    2NDC:65841-779-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    3NDC:65841-779-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    4NDC:65841-779-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    5NDC:65841-779-77100 in 1 CARTON02/15/2014
    5NDC:65841-779-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09113402/15/2014
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-777, 65841-778, 65841-779) , MANUFACTURE(65841-777, 65841-778, 65841-779)
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