Label: CLONIDINE HYDROCHLORIDE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated April 4, 2019

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  • SPL Unclassified

  • Description

  • Clinical Pharmacology

  • Indications and Usage

  • Contraindications

  • Warnings

  • Precautions

  • Adverse Reactions

  • Overdosage

  • Dosage and Administration

  • How Supplied

  • Package Label

    label

  • PRINCIPAL DISPLAY PANEL

    605-90

  • INGREDIENTS AND APPEARANCE
    CLONIDINE HYDROCHLORIDE 
    clonidine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-268(NDC:29300-137)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE0.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code U;137
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-268-6060 in 1 BOTTLE; Type 0: Not a Combination Product12/29/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07889512/29/2015
    CLONIDINE HYDROCHLORIDE 
    clonidine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-605(NDC:62332-054)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE0.1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Colorbrown (Light Tan) Score2 pieces
    ShapeOVAL (Oval,Biconvex) Size7mm
    FlavorImprint Code L167
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-605-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09136804/04/2019
    Labeler - DirectRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRX079254320repack(61919-268, 61919-605)