ULTRAM (TRAMADOL HCL) TABLET, COATED [NORTHWIND PHARMACEUTICALS]

ULTRAM (TRAMADOL HCL) TABLET, COATED [NORTHWIND PHARMACEUTICALS]
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NDC 51655-185-20
Set ID 3f12e8b3-ccf5-4b7d-a370-9596e5002b10
Category HUMAN PRESCRIPTION DRUG LABEL
Packager NORTHWIND PHARMACEUTICALS
Generic Name
Product Class
Product Number
Application Number ANDA076003
  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-0185-20

    MFG: 65162-627-11

    traMADOL HCL 50 MG

    20 TABLETS  RX ONLY

    DOSAGE: SEE PACKAGE INSERT

    STORE AT 68 TO 77 DEGREES F

    STORE IN A TIGHT, LIGHT-RESISTANT CONTAINER. (SEE USP) KEEP OUT OF REACH OF CHILDREN

    EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE USP 50 MG

    MFG BY: AMNEAL PHARMACEUTICALS PVT LTD AHMEDABAD INDIA 382220

    REPACKAGED BY NORTHWIND PHARMACEUTICALS INDIANAPOLIS, IN 46256

    LOT# NW76700002

    EXP DATE: 09/2016

    51655 0185 20

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    ULTRAM 
    tramadol hcl tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-185(NDC:65162-627)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE50 mg  in 20 
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code AN627
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-185-2020 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07600302/13/2014
    Labeler - NORTHWIND PHARMACEUTICALS (036986393)
    Registrant - NORTHWIND PHARMACEUTICALS (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHWIND PHARMACEUTICALS036986393repack(51655-185)

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