NDC 68727-100

Xyrem

Sodium Oxybate

Xyrem is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Sodium Oxybate.

Product ID68727-100_39820038-ac66-4e6a-8386-3ba1efb64ceb
NDC68727-100
Product TypeHuman Prescription Drug
Proprietary NameXyrem
Generic NameSodium Oxybate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2002-07-17
Marketing CategoryNDA / NDA
Application NumberNDA021196
Labeler NameJazz Pharmaceuticals, Inc.
Substance NameSODIUM OXYBATE
Active Ingredient Strength1 g/mL
Pharm ClassesCentral Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68727-100-01

180 mL in 1 BOTTLE, PLASTIC (68727-100-01)
Marketing Start Date2002-07-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68727-100-01 [68727010001]

Xyrem SOLUTION
Marketing CategoryNDA
Application NumberNDA021196
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2002-07-17

Drug Details

Active Ingredients

IngredientStrength
SODIUM OXYBATE.5 g/mL

OpenFDA Data

SPL SET ID:926eb076-a4a8-45e4-91ef-411f0aa4f3ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349482
  • 352257
  • Pharmacological Class

    • Central Nervous System Depressant [EPC]
    • Central Nervous System Depression [PE]
    • Decreased Central Nervous System Organized Electrical Activity [PE]
    • Central Nervous System Depressant [EPC]
    • Central Nervous System Depression [PE]
    • Decreased Central Nervous System Organized Electrical Activity [PE]

    NDC Crossover Matching brand name "Xyrem" or generic name "Sodium Oxybate"

    NDCBrand NameGeneric Name
    68727-100Xyremsodium oxybate
    0054-9628N/Asodium oxybate

    Trademark Results [Xyrem]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XYREM
    XYREM
    78978081 3428812 Dead/Cancelled
    Orphan Medical, Inc.
    2005-12-08
    XYREM
    XYREM
    78769797 not registered Dead/Abandoned
    Orphan Medical, Inc.
    2005-12-08
    XYREM
    XYREM
    78769796 3309255 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    2005-12-08
    XYREM
    XYREM
    78769631 3162636 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    2005-12-08
    XYREM
    XYREM
    78769629 3162635 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    2005-12-08
    XYREM
    XYREM
    78769626 3162634 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    2005-12-08
    XYREM
    XYREM
    78769623 3162633 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    2005-12-08
    XYREM
    XYREM
    78769619 3162632 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    2005-12-08
    XYREM
    XYREM
    78400994 3112732 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    2004-04-13
    XYREM
    XYREM
    76327130 2860730 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    2001-10-17
    XYREM
    XYREM
    75701032 2472156 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    1998-10-27
    XYREM
    XYREM
    75577530 2423880 Live/Registered
    JAZZ PHARMACEUTICALS, INC.
    1998-10-27

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