Label: LABETALOL HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 70771-1163-1, 70771-1163-3, 70771-1163-5, 70771-1163-9, view more
    70771-1164-1, 70771-1164-3, 70771-1164-5, 70771-1164-9, 70771-1165-1, 70771-1165-3, 70771-1165-5, 70771-1165-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1163-3

    Labetalol  hydrochloride tablets, 100 mg

    Rx only

    30 tablets

    Labetalol  hydrochloride tablets

    NDC 70771-1164-3

    Labetalol  hydrochloride tablets, 200 mg

    Rx only

    30 tablets

    Labetalol  hydrochloride tablets

    NDC 70771-1165-3

    Labetalol  hydrochloride tablets, 300 mg

    Rx only

    30 tablets

    Labetalol  hydrochloride tablets
  • INGREDIENTS AND APPEARANCE
    LABETALOL HYDROCHLORIDE 
    labetalol hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1163
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeROUND (BICONVEX) Size8mm
    FlavorImprint Code 7;98
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1163-330 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    2NDC:70771-1163-990 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    3NDC:70771-1163-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    4NDC:70771-1163-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20774312/05/2017
    LABETALOL HYDROCHLORIDE 
    labetalol hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1164
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Score2 pieces
    ShapeROUND (BICONVEX) Size11mm
    FlavorImprint Code 7;99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1164-330 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    2NDC:70771-1164-990 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    3NDC:70771-1164-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    4NDC:70771-1164-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20774312/05/2017
    LABETALOL HYDROCHLORIDE 
    labetalol hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE300 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREEN (LIGHT GREEN) Scoreno score
    ShapeROUND (BICONVEX) Size11mm
    FlavorImprint Code 800
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1165-330 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    2NDC:70771-1165-990 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    3NDC:70771-1165-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    4NDC:70771-1165-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20774312/05/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1163, 70771-1164, 70771-1165) , MANUFACTURE(70771-1163, 70771-1164, 70771-1165)