Label: SODIUM BICARBONATE- sodium bicarbonate solution 

  • NDC Code(s): 25021-501-66
  • Packager: Sagent Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

Drug Label Information

Updated 02/13

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  • HEALTH CARE PROVIDER LETTER

    SAGENT™

    Sagent Pharmaceuticals, Inc.

    1901 N. Roselle Road, Suite 700
    Schaumburg, IL 60195
    (847) 908-1600 Main
    (847) 908-1601 Fax
    www.SagentPharma.com

    URGENT – Sodium Bicarbonate Injection Shortage Update

    January 7, 2013

    Dear Healthcare Professional,

    Due to the current critical shortage of Sodium Bicarbonate Injection, USP in the United States (US) market, Sagent Pharmaceuticals, Inc. (Sagent) is coordinating with the Food and Drug Administration (FDA) to increase the availability of Sodium Bicarbonate Injection. In cooperation with the FDA, Sagent has initiated temporary importation of a non FDA approved 8.4% Sodium Bicarbonate Injection (1 mEq/mL) from Phebra Pty Ltd (Phebra), Australia into the US market.

    Phebra's Sodium Bicarbonate Injection contains the same active ingredient, Sodium Bicarbonate, in the same strength and concentration, 8.4% (1 mEq/mL) as the US registered Sodium Bicarbonate Injection, USP by Hospira. However, it is important to note that Phebra's Sodium Bicarbonate Injection (1 mEq/mL), is provided only in a Single Use 10 mL vial, whereas Hospira's product is provided in 50 mL single-dose vials and syringes. Any unused portion of Phebra's Sodium Bicarbonate Injection (1 mEq/mL) should be discarded after a single use.

    Please refer to the US approved package insert at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails for the full prescribing information for8.4% Sodium Bicarbonate Injection (1 mEq/mL).

    Phebra's Sodium Bicarbonate labeling does not include an NDC number. To order Phebra's 8.4% Sodium Bicarbonate Injection, (1 mEq/mL), 10 mL vial, please contact your Sagent Regional Business Manager or call Sagent's Customer Service at 1-866-625-1618 and reference item number 32982.

    To report adverse events or medication errors among patients who have received Phebra's 8.4% Sodium Bicarbonate Injection, (1 mEq/mL), 10 mL vial, please contact Medical Affairs by phone at 1-866-625-1618. Adverse events may also be reported to FDA's MedWatch Adverse Reporting Program either online, by regular mail or fax:

    • Online: www.fda.gov/medwatch/report.htm
    • Regular Mail: use postage-paid FDA Form 3500 available at www.fda.gov/Medwatch/getforms.htm. Mail to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
    • Fax: 1-800-FDA-0178

    If you have any questions about the information contained in this letter or the safe and effective use of Phebra's 8.4% Sodium Bicarbonate Injection, (1 mEq/mL), 10 mL vial, please contact Sagent's Medical Affairs at 1-866-625-1618.

    At this time, no other entity except Sagent Pharmaceuticals, Inc. is authorized by the FDA to import or distribute Phebra's 8.4% Sodium Bicarbonate Injection, (1 mEq/mL), 10 mL vials, in the United States. Any sales of this product from any entity other than Sagent Pharmaceuticals, Inc. or a distributor or re-seller authorized by Sagent Pharmaceuticals, Inc. could be a violation of the Federal Food, Drug and Cosmetic Act and is subject to enforcement by the FDA.

    Sincerely,




    Thomas J. Moutvic
    Vice President, Regulatory Affairs
    Sagent Pharmaceuticals, Inc.

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

    Sodium Bicarbonate

    8.4% Injection 840mg in 10mL

    10 x 10mL vials

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
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  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:25021-501
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    sodium bicarbonate (sodium cation and bicarbonate ion) sodium bicarbonate 84 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:25021-501-66 10 in 1 CARTON
    1 10 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug for use in drug shortage 10/02/2012 01/31/2015
    Labeler - Sagent Pharmaceuticals (796852890)
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