Label: ENOXAPARIN SODIUM injection, solution

  • NDC Code(s): 11797-757-02, 11797-757-06, 11797-758-02, 11797-758-06, view more
    11797-759-02, 11797-759-06, 11797-760-02, 11797-760-06, 11797-761-02, 11797-761-06, 11797-762-02, 11797-762-06, 11797-763-02, 11797-763-06
  • Packager: Italfarmaco SpA
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 30, 2021

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 11797-757-06

    Enoxaparin Sodium Injection USP

    30 mg/0.3 mL

    SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

    FOR SUBCUTANEOUS INJECTION

    Ten 0.3 mL Syringes

    30 mg

    NDC 11797-758-06

    Enoxaparin Sodium Injection USP

    40 mg/0.4 mL

    SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

    FOR SUBCUTANEOUS INJECTION

    Ten 0.4 mL Syringes

    40 mg

    NDC 11797-759-06

    Enoxaparin Sodium Injection USP

    60 mg/0.6 mL

    SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

    FOR SUBCUTANEOUS INJECTION

    Ten 0.6 mL Syringes

    60 mg

    NDC 11797-760-06

    Enoxaparin Sodium Injection USP

    80 mg/0.8 mL

    SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

    FOR SUBCUTANEOUS INJECTION

    Ten 0.8 mL Syringes

    80 mg

    NDC 11797-761-06

    Enoxaparin Sodium Injection USP

    100 mg/1 mL

    SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

    FOR SUBCUTANEOUS INJECTION

    Ten 1 mL Syringes

    100 mg

    NDC 11797-762-06

    Enoxaparin Sodium Injection USP

    120 mg/0.8 mL

    SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

    FOR SUBCUTANEOUS INJECTION

    Ten 0.8 mL Syringes

    120 mg

    NDC 11797-763-06

    Enoxaparin Sodium Injection USP

    150 mg/1 mL

    SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

    FOR SUBCUTANEOUS INJECTION

    Ten 1 mL Syringes

    150 mg
  • INGREDIENTS AND APPEARANCE
    ENOXAPARIN SODIUM 
    enoxaparin sodium injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11797-757
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV) ENOXAPARIN SODIUM30 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11797-757-0610 in 1 CARTON04/01/2021
    1NDC:11797-757-020.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07672604/01/2021
    ENOXAPARIN SODIUM 
    enoxaparin sodium injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11797-758
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV) ENOXAPARIN SODIUM40 mg  in 0.4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11797-758-0610 in 1 CARTON04/01/2021
    1NDC:11797-758-020.4 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07672604/01/2021
    ENOXAPARIN SODIUM 
    enoxaparin sodium injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11797-759
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV) ENOXAPARIN SODIUM60 mg  in 0.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11797-759-0610 in 1 CARTON04/01/2021
    1NDC:11797-759-020.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07672604/01/2021
    ENOXAPARIN SODIUM 
    enoxaparin sodium injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11797-760
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV) ENOXAPARIN SODIUM80 mg  in 0.8 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11797-760-0610 in 1 CARTON04/01/2021
    1NDC:11797-760-020.8 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07672604/01/2021
    ENOXAPARIN SODIUM 
    enoxaparin sodium injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11797-761
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV) ENOXAPARIN SODIUM100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11797-761-0610 in 1 CARTON04/01/2021
    1NDC:11797-761-021 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07672604/01/2021
    ENOXAPARIN SODIUM 
    enoxaparin sodium injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11797-762
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV) ENOXAPARIN SODIUM120 mg  in 0.8 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11797-762-0610 in 1 CARTON04/01/2021
    1NDC:11797-762-020.8 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07672604/01/2021
    ENOXAPARIN SODIUM 
    enoxaparin sodium injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11797-763
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV) ENOXAPARIN SODIUM150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11797-763-0610 in 1 CARTON04/01/2021
    1NDC:11797-763-021 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07672604/01/2021
    Labeler - Italfarmaco SpA (428179329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Italfarmaco SpA428179329ANALYSIS(11797-757, 11797-758, 11797-759, 11797-760, 11797-761, 11797-762, 11797-763) , LABEL(11797-757, 11797-758, 11797-759, 11797-760, 11797-761, 11797-762, 11797-763) , MANUFACTURE(11797-757, 11797-758, 11797-759, 11797-760, 11797-761, 11797-762, 11797-763) , PACK(11797-757, 11797-758, 11797-759, 11797-760, 11797-761, 11797-762, 11797-763)