Label: MINOCYCLINE HYDROCHLORIDE capsule

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

Drug Label Information

Updated January 21, 2020

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  • SPL Unclassified

    Rx only

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

  • Description

  • Clinical Pharmacology

  • INDICATIONS & USAGE

  • Contraindications

  • Warnings

  • Precautions

  • Adverse Reactions

  • Overdosage

  • Dosage and Administration

  • Animal Pharmacology and Toxicology

  • Patient Information

  • PRINCIPAL DISPLAY PANEL

    270

  • INGREDIENTS AND APPEARANCE
    MINOCYCLINE HYDROCHLORIDE 
    minocycline hydrochloride capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-270(NDC:13668-484)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO) MINOCYCLINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SHELLAC (UNII: 46N107B71O)  
    GELATIN (UNII: 2G86QN327L)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorgray (gray opaque cap, white opaque body) Scoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code RX696
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-270-2020 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06506203/14/2018
    Labeler - DirectRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRX079254320repack(61919-270)