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

Drug Label Information

Updated September 26, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!