PROBENECID tablet, film coated

Probenecid by

Drug Labeling and Warnings

Probenecid by is a Prescription medication manufactured, distributed, or labeled by Lannett Company, Inc., Firmplace Yerevan, Kremers Urban Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • HOW SUPPLIED

    Probenecid Tablets, USP are available containing 500 mg of Probenecid, USP.

    The tablets are capsule shaped, film-coated yellow, debossed LCI on one side and 1367 on the other side. They are available as follows:

    NDC: 0527-1367-01     bottles of 100 tablets

    NDC: 0527-1367-10     bottles of 1000 tablets

    STORE AT 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]

    PROTECT FROM LIGHT.

    Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

    Distributed by:
    Lannett Company, Inc.
    Philadelphia, PA 19136

    CIB70317B
    Rev 04/16

  • PRINCIPAL DISPLAY PANEL

    NDC: 0527-1367-10

    Lannett

    PROBENECID
    TABLETS, USP

    500 mg

    Rx Only

    1000 TABLETS

    probenecid-500mg-1000count-container-label
  • INGREDIENTS AND APPEARANCE
    PROBENECID 
    probenecid tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0527-1367
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROBENECID (UNII: PO572Z7917) (PROBENECID - UNII:PO572Z7917) PROBENECID500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorYELLOW (Yellow) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code LCI;1367
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0527-1367-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/29/1976
    2NDC: 0527-1367-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/29/1976
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08096607/29/1976
    Labeler - Lannett Company, Inc. (002277481)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lannett Company, Inc.829757603ANALYSIS(0527-1367)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lannett Company, Inc.006422406LABEL(0527-1367) , MANUFACTURE(0527-1367) , PACK(0527-1367) , RELABEL(0527-1367) , REPACK(0527-1367)

  • © 2021 FDA.report
    This site is not affiliated with or endorsed by the FDA.