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 December 3, 2024

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

View All Sections
  • 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)
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!