Label: CARBIDOPA AND LEVODOPA tablet

  • NDC Code(s): 70771-1694-0, 70771-1694-1, 70771-1694-5, 70771-1695-0, view more
    70771-1695-1, 70771-1695-5, 70771-1696-0, 70771-1696-1, 70771-1696-5
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 11, 2023

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1694-1

    Carbidopa and Levodopa Tablets, USP 10 mg/100 mg

    100 Tablets

    Rx only

    10 mg/100 mg label

    NDC 70771-1695-1

    Carbidopa and Levodopa Tablets, USP 25 mg/100 mg

    100 Tablets

    Rx only

    25 mg/100 mg label

    NDC 70771-1696-1

    Carbidopa and Levodopa Tablets, USP 25 mg/250 mg

    100 Tablets

    Rx only

    25 mg/250 mg label
  • INGREDIENTS AND APPEARANCE
    CARBIDOPA AND LEVODOPA 
    carbidopa and levodopa tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1694
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) CARBIDOPA ANHYDROUS10 mg
    LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) LEVODOPA100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBLUE (light blue) Score2 pieces
    ShapeROUND (round) Size8mm
    FlavorImprint Code 1721
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1694-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2024
    2NDC:70771-1694-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2024
    3NDC:70771-1694-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21599908/24/2024
    CARBIDOPA AND LEVODOPA 
    carbidopa and levodopa tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1695
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) CARBIDOPA ANHYDROUS25 mg
    LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) LEVODOPA100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (light yellow) Score2 pieces
    ShapeROUND (round) Size8mm
    FlavorImprint Code 1722
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1695-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2024
    2NDC:70771-1695-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2024
    3NDC:70771-1695-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21599908/24/2024
    CARBIDOPA AND LEVODOPA 
    carbidopa and levodopa tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1696
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) CARBIDOPA ANHYDROUS25 mg
    LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) LEVODOPA250 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBLUE (light blue) Score2 pieces
    ShapeROUND (round) Size10mm
    FlavorImprint Code 1723
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1696-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2024
    2NDC:70771-1696-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2024
    3NDC:70771-1696-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21599908/24/2024
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1694, 70771-1695, 70771-1696) , MANUFACTURE(70771-1694, 70771-1695, 70771-1696)
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