Label: OSELTAMIVIR PHOSPHATE capsule

  • NDC Code(s): 70771-1710-2, 70771-1711-2, 70771-1712-2
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1710-2

    OSELTAMIVIR PHOSPHATE Capsules, USP

    30* mg

    *Each capsule contains oseltamivir phosphate equivalent to 30 mg oseltamivir (free base).

    10 Capsules

    (1 x 10 Unit-Dose)

    Rx only

    30 mg label

    NDC 70771-1711-2

    OSELTAMIVIR PHOSPHATE Capsules, USP

    45* mg

    *Each capsule contains oseltamivir phosphate equivalent to 45 mg oseltamivir (free base).

    10 Capsules

    (1 x 10 Unit-Dose)

    Rx only

    45 mg label

    NDC 70771-1712-2

    OSELTAMIVIR PHOSPHATE Capsules, USP

    75* mg

    *Each capsule contains oseltamivir phosphate equivalent to 75 mg oseltamivir (free base).

    10 Capsules

    (1 x 10 Unit-Dose)

    Rx only

    75 mg label
  • INGREDIENTS AND APPEARANCE
    OSELTAMIVIR PHOSPHATE 
    oseltamivir phosphate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1710
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OSELTAMIVIR PHOSPHATE (UNII: 4A3O49NGEZ) (OSELTAMIVIR ACID - UNII:K6106LV5Q8) OSELTAMIVIR ACID30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code N;1008
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1710-21 in 1 CARTON02/24/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20857802/24/2017
    OSELTAMIVIR PHOSPHATE 
    oseltamivir phosphate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1711
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OSELTAMIVIR PHOSPHATE (UNII: 4A3O49NGEZ) (OSELTAMIVIR ACID - UNII:K6106LV5Q8) OSELTAMIVIR ACID45 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGRAY (Light Blue Gray) , GRAY (Light Blue Gray) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code N;1009
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1711-21 in 1 CARTON02/24/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20857802/24/2017
    OSELTAMIVIR PHOSPHATE 
    oseltamivir phosphate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1712
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OSELTAMIVIR PHOSPHATE (UNII: 4A3O49NGEZ) (OSELTAMIVIR ACID - UNII:K6106LV5Q8) OSELTAMIVIR ACID75 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGRAY (Light Blue Gray) , WHITEScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code N;1010
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1712-21 in 1 CARTON02/24/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20857802/24/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1710, 70771-1711, 70771-1712) , MANUFACTURE(70771-1710, 70771-1711, 70771-1712)
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