Label: CLONIDINE HYDROCHLORIDE- 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
  • INGREDIENTS AND APPEARANCE
    CLONIDINE HYDROCHLORIDE 
    clonidine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-268(NDC:29300-137)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE 0.3 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code U;137
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61919-268-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/29/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078895 12/29/2015
    CLONIDINE HYDROCHLORIDE 
    clonidine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-605(NDC:62332-054)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE 0.1 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color brown (Light Tan) Score 2 pieces
    Shape OVAL (Oval,Biconvex) Size 7mm
    Flavor Imprint Code L167
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61919-605-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091368 04/04/2019
    Labeler - DirectRX (079254320)
    Establishment
    Name Address ID/FEI Business Operations
    DirectRX 079254320 repack(61919-268, 61919-605)
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