Label: BUPROPION tablet, extended release

  • NDC Code(s): 65841-780-05, 65841-780-06, 65841-780-10, 65841-780-16, view more
    65841-836-05, 65841-836-06, 65841-836-10, 65841-836-16
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 20, 2023

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

View All Sections
  • MEDICATION GUIDE

    Manufactured by:

    Cadila Healthcare Ltd.

    India.

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-780-05

    Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg

    500 Tablets

    Rx only

    Bupropion hydrochloride extended-release tablets, USP (XL)

    NDC 65841-836-05

    Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg

    500 Tablets

    Rx only

    label
  • INGREDIENTS AND APPEARANCE
    BUPROPION 
    bupropion tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-780
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31) BUPROPION HYDROCHLORIDE300 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    POVIDONE (UNII: FZ989GH94E)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorYELLOW (CREAMY WHITE TO PALE YELLOW) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 354
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-780-0630 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    2NDC:65841-780-1690 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    3NDC:65841-780-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    4NDC:65841-780-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20156702/15/2014
    BUPROPION 
    bupropion tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-836
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31) BUPROPION HYDROCHLORIDE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    POVIDONE (UNII: FZ989GH94E)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorYELLOW (CREAMY WHITE TO PALE YELLOW) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 353
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-836-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2018
    2NDC:65841-836-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2018
    3NDC:65841-836-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2018
    4NDC:65841-836-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20156708/02/2018
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-780, 65841-836) , MANUFACTURE(65841-780, 65841-836)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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