Label: PEMETREXED- pemetrexed disodium injection, powder, lyophilized, for solution

  • NDC Code(s): 70771-1691-1, 70771-1692-1, 70771-1693-1
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 26, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1691-1

    Pemetrexed for Injection, USP

    100 mg/vial

    For intravenous use only.

    Single-Dose Vial

    Rx only

    100 mg vial label

    NDC 70771-1691-1

    Pemetrexed for Injection, USP

    100 mg/vial

    For intravenous use only.

    One Single-Dose Vial Carton

    Rx only

    100 mg carton label

    NDC 70771-1692-1

    Pemetrexed for Injection, USP

    500 mg/vial

    For intravenous use only.

    Single-Dose Vial

    Rx only

    500 mg vial label

    NDC 70771-1692-1

    Pemetrexed for Injection, USP

    500 mg/vial

    For intravenous use only.

    One Single-Dose Vial Carton

    Rx only

    500 mg carton label

    NDC 70771-1693-1

    Pemetrexed for Injection, USP

    1000 mg/vial

    For intravenous use only.

    Single-Dose Vial

    Rx only

    1,000 mg vial label

    NDC 70771-1693-1

    Pemetrexed for Injection, USP

    1000 mg/vial

    For intravenous use only.

    One Single-Dose Vial Carton

    Rx only

    1,000 mg carton label
  • INGREDIENTS AND APPEARANCE
    PEMETREXED 
    pemetrexed disodium injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1691
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEMETREXED DISODIUM (UNII: 2PKU919BA9) (PEMETREXED - UNII:04Q9AIZ7NO) PEMETREXED100 mg  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A) 106 mg  in 4 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1691-11 in 1 CARTON05/26/2022
    14 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21407305/26/2022
    PEMETREXED 
    pemetrexed disodium injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1692
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEMETREXED DISODIUM (UNII: 2PKU919BA9) (PEMETREXED - UNII:04Q9AIZ7NO) PEMETREXED500 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A) 500 mg  in 20 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1692-11 in 1 CARTON05/26/2022
    120 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21407305/26/2022
    PEMETREXED 
    pemetrexed disodium injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1693
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEMETREXED DISODIUM (UNII: 2PKU919BA9) (PEMETREXED - UNII:04Q9AIZ7NO) PEMETREXED1000 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A) 1000 mg  in 40 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1693-11 in 1 CARTON05/26/2022
    140 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21407305/26/2022
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Hospira Oncology Private Limited676190889ANALYSIS(70771-1691, 70771-1692, 70771-1693) , LABEL(70771-1691, 70771-1692, 70771-1693) , MANUFACTURE(70771-1691, 70771-1692, 70771-1693) , PACK(70771-1691, 70771-1692, 70771-1693)
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