Label: VERAPAMIL HYDROCHLORIDE injection, solution

  • NDC Code(s): 70771-1601-1, 70771-1601-5, 70771-1601-7, 70771-1602-1, view more
    70771-1602-5
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 17, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1601-1

    Verapamil Hydrochloride Injection, USP

    5 mg/2 mL

    (2.5 mg/mL)

    For Intravenous Use Only

    Protect from light.

    2 mL Single-Dose Vial 

    Rx only

    2 mL vial

    NDC 70771-1601-5

    Verapamil Hydrochloride Injection, USP

    5 mg/2 mL

    (2.5 mg/mL)

    For Intravenous Use Only

    Protect from light.

    5 X 2 mL Single-Dose Vials 

    Rx only

    carton of 5 vials

    NDC 70771-1601-7

    Verapamil Hydrochloride Injection, USP

    5 mg/2 mL

    (2.5 mg/mL)

    For Intravenous Use Only

    Protect from light.

    25 X 2 mL Single-Dose Vials 

    Rx only

    carton of 25 vials
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1602-1

    Verapamil Hydrochloride Injection, USP

    10 mg/4 mL

    (2.5 mg/mL)

    For Intravenous Use Only

    Protect from light.

    4 mL Single-Dose Vial 

    Rx only

    4 mL vial

    NDC 70771-1602-5

    Verapamil Hydrochloride Injection, USP

    10 mg/4 mL

    (2.5 mg/mL)

    For Intravenous Use Only

    Protect from light.

    5 X 4 mL Single-Dose Vials 

    Rx only

    carton of 5 vials
  • INGREDIENTS AND APPEARANCE
    VERAPAMIL HYDROCHLORIDE 
    verapamil hydrochloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1601
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29) VERAPAMIL HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 8.5 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1601-725 in 1 CARTON10/22/2020
    1NDC:70771-1601-55 in 1 CARTON
    1NDC:70771-1601-12 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21421510/22/2020
    VERAPAMIL HYDROCHLORIDE 
    verapamil hydrochloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1602
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29) VERAPAMIL HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 8.5 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1602-55 in 1 CARTON10/22/2020
    1NDC:70771-1602-14 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21421510/22/2020
    Labeler - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited873671928MANUFACTURE(70771-1601, 70771-1602) , ANALYSIS(70771-1601, 70771-1602)