LOSARTAN POTASSIUM TABLET [DIRECTRX]

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LOSARTAN POTASSIUM TABLET [DIRECTRX]
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NDC 61919-461-30
Set ID 25fe6b18-e408-4b17-e054-00144ff8d46c
Category HUMAN PRESCRIPTION DRUG LABEL
Packager DirectRX
Generic Name
Product Class Angiotensin 2 Receptor Blocker
Product Number
Application Number ANDA090467
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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.

  • Description

  • Clinical Pharmacology

    Clinical Pharmacology Continued

  • Indications and Usage

  • Contraindications

  • Warnings

  • Precautions

  • Adverse Reactions

  • Overdosage

  • Dosage and Administration

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    LOSARTAN POTASSIUM 
    losartan potassium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-461(NDC:13668-113)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorwhite (white to off-white) Scoreno score
    ShapeOVAL (oval shaped, biconvex) Size8mm
    FlavorImprint Code 25;113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-461-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09046712/03/2015
    Labeler - DirectRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRX079254320repack(61919-461)
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