Label: LOSARTAN POTASSIUM- losartan potassium tablet

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

Drug Label Information

Updated December 3, 2015

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  • BOXED WARNING(What is this?)

    Boxed Warning

    fetal toxicity

    When pregnancy is detected, discontinue losartan potassium tablets as soon as possible.
    Drugs that act directly on the rennin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity.

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  • Description
  • Clinical Pharmacology

    Clinical Pharmacology Continued

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  • Indications and Usage
  • Contraindications
  • Warnings
  • Precautions
  • Adverse Reactions
  • Overdosage
  • Dosage and Administration
  • Package Label
  • INGREDIENTS AND APPEARANCE
    LOSARTAN POTASSIUM 
    losartan potassium tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-461(NDC:13668-113)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (white to off-white) Score no score
    Shape OVAL (oval shaped, biconvex) Size 8mm
    Flavor Imprint Code 25;113
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61919-461-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/03/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090467 12/03/2015
    Labeler - DirectRX (079254320)
    Establishment
    Name Address ID/FEI Business Operations
    DirectRX 079254320 repack(61919-461)
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