Label: PROPRANOLOL HYDROCHLORIDE capsule, extended release

  • NDC Code(s): 65841-745-01, 65841-745-05, 65841-745-10, 65841-745-16, view more
    65841-745-30, 65841-745-77, 65841-746-01, 65841-746-05, 65841-746-10, 65841-746-16, 65841-746-30, 65841-746-77, 65841-747-01, 65841-747-05, 65841-747-10, 65841-747-16, 65841-747-30, 65841-747-77, 65841-748-01, 65841-748-05, 65841-748-10, 65841-748-16, 65841-748-30, 65841-748-77
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 14, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-745-01 in bottle of 100 Capsules

    Propranolol Hydrochloride Extended-release Capsules USP, 60 mg

    Rx only

    100 CAPSULES

    Structured formula for propranolol

    NDC 65841-746-01 in bottle of 100 Capsules

    Propranolol Hydrochloride Extended-release Capsules USP, 80 mg

    Rx only

    100 CAPSULES

    Structured formula for propranolol

    NDC 65841-747-01 in bottle of 100 Capsules

    Propranolol Hydrochloride Extended-release Capsules USP, 120 mg

    Rx only

    100 CAPSULES

    Structured formula for propranolol

    NDC 65841-748-01 in bottle of 100 Capsules

    Propranolol Hydrochloride Extended-release Capsules USP, 160 mg

    Rx only

    100 CAPSULES

    Structural formula for propranolol
  • INGREDIENTS AND APPEARANCE
    PROPRANOLOL HYDROCHLORIDE 
    propranolol hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-745
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE) , BLUE (LIGHT BLUE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code ZA;57;60;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-745-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    2NDC:65841-745-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    3NDC:65841-745-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    4NDC:65841-745-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    5NDC:65841-745-77100 in 1 CARTON04/15/2014
    5NDC:65841-745-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09032104/15/2014
    PROPRANOLOL HYDROCHLORIDE 
    propranolol hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-746
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorBLUE (LIGHT BLUE) , BLUE (LIGHT BLUE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code ZA;58;80;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-746-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    2NDC:65841-746-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    3NDC:65841-746-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    4NDC:65841-746-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    5NDC:65841-746-77100 in 1 CARTON04/15/2014
    5NDC:65841-746-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09032104/15/2014
    PROPRANOLOL HYDROCHLORIDE 
    propranolol hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-747
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorBLUE (DARK BLUE) , BLUE (LIGHT BLUE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size18mm
    FlavorImprint Code ZA;59;120;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-747-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    2NDC:65841-747-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    3NDC:65841-747-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    4NDC:65841-747-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    5NDC:65841-747-77100 in 1 CARTON04/15/2014
    5NDC:65841-747-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09032104/15/2014
    PROPRANOLOL HYDROCHLORIDE 
    propranolol hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-748
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE160 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorBLUE (DARK BLUE) , BLUE (DARK BLUE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code ZA;60;160;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-748-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    2NDC:65841-748-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    3NDC:65841-748-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    4NDC:65841-748-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
    5NDC:65841-748-77100 in 1 CARTON04/15/2014
    5NDC:65841-748-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09032104/15/2014
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-745, 65841-746, 65841-747, 65841-748) , MANUFACTURE(65841-745, 65841-746, 65841-747, 65841-748)
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