Label: CITALOPRAM HYDROBROMIDE- citalopram hydrobromide tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 3, 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-670-52

    MFG: 57664-509-13

    Citalopram 40 MG

    30 TABLETS

    RX ONLY

    Dosage: See package insert

    Store at 68 to 77 degrees F.

    Keep out of reach of children.

    Each  tablet contains Citalopram hydrobromide, UPS equivalent to 40mg citalopram base

    Mfg by: Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India

    Distributed by Caraco Pharmaceuticals Laboratories, Ltd, 1150 Elijah McCoy Drive, Detroit, MI 48202

    Batch # JKM4285A

    Repackaged by Northwind Pharmaceuticals Indianapolis, IN 46256

    Lot # NW89530001 EXP Date: 10/2015

    Citalopram 40

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  • INGREDIENTS AND APPEARANCE
    CITALOPRAM HYDROBROMIDE 
    citalopram hydrobromide tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-670(NDC:57664-509)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V) CITALOPRAM 40 mg  in 30 
    Product Characteristics
    Color white Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code 509
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51655-670-52 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077032 04/03/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    Name Address ID/FEI Business Operations
    Northwind Pharmaceuticals 036986393 repack(51655-670)
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