Label: NAPROXEN tablet

  • NDC Code(s): 65841-676-01, 65841-676-10, 65841-677-01, 65841-677-05, view more
    65841-677-10, 65841-678-01, 65841-678-05, 65841-678-10
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 1, 2020

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

  • MEDICATION GUIDE

    Manufactured by:

    Cadila Healthcare Ltd.

    India

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-676-01

    Naproxen tablets, 250 mg

    100 Tablets

    Rx only

    Naproxen tablets

    NDC 65841-677-01

    Naproxen tablets, 375 mg

    100 Tablets

    Rx only

    Naproxen tablets

    NDC 65841-678-01

    Naproxen tablets, 500 mg

    100 Tablets

    Rx only

    Naproxen tablets
  • INGREDIENTS AND APPEARANCE
    NAPROXEN 
    naproxen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-676
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code ZE10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-676-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
    2NDC:65841-676-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07862011/09/2017
    NAPROXEN 
    naproxen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-677
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN375 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorYELLOW (yellow) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code ZE9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-677-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
    2NDC:65841-677-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
    3NDC:65841-677-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07862011/09/2017
    NAPROXEN 
    naproxen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-678
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeCAPSULESize16mm
    FlavorImprint Code ZE8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-678-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
    2NDC:65841-678-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
    3NDC:65841-678-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07862011/09/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-676, 65841-677, 65841-678) , MANUFACTURE(65841-676, 65841-677, 65841-678)