CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]
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NDC 51655-439-52
Set ID 0e2c0580-49d7-4bd5-85df-7a3591198ab0
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Northwind Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number ANDA073144
  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-439-52

    MFG: 0378-0751-10

    Cyclobenzaprine HCL 10 MG

    30 Tablets

    Rx only

    Lot#: NW20750001

    Exp. Date: 2/2015

    Each film-coated tablet contains: Cyclobenzaprine hydrochloride, USP...10mg

    Dosage: See package insert

    Store at 68 to 77 degrees F.

    Protect from moisture. Store in a tight, light-resistant container (See USP)

    Keep out of the reach of children.

    Mfg. By: Mylan Pharmaceuticals, Inc. Morgantown, WV 26505 USA Lot # 3044836

    Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

    Cyclobenzaprine 51655-439

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    CYCLOBENZAPRINE HYDROCHLORIDE 
    cyclobenzaprine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-439(NDC:0378-0751)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE10 mg  in 30 
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code M;751
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-439-5230 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07314405/16/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-439)

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