NDC 10544-524

SKELAXIN

Metaxalone

SKELAXIN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Metaxalone.

Product ID10544-524_11a55d5f-72ba-0b65-e054-00144ff88e88
NDC10544-524
Product TypeHuman Prescription Drug
Proprietary NameSKELAXIN
Generic NameMetaxalone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-03-15
Marketing CategoryNDA / NDA
Application NumberNDA013217
Labeler NameBlenheim Pharmacal, Inc.
Substance NameMETAXALONE
Active Ingredient Strength800 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-524-20

20 TABLET in 1 BOTTLE (10544-524-20)
Marketing Start Date2012-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-524-20 [10544052420]

SKELAXIN TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
METAXALONE800 mg/1

OpenFDA Data

SPL SET ID:11a55d5f-72b9-0b65-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 352277
  • 351254
    • UPC Code
  • 0310544524208

    • Pharmacological Class

    • Centrally-mediated Muscle Relaxation [PE]

    NDC Crossover Matching brand name "SKELAXIN" or generic name "Metaxalone"

    NDCBrand NameGeneric Name
    10544-524SKELAXINmetaxalone
    21695-123SkelaxinMetaxalone
    68788-0881SkelaxinSkelaxin
    55289-736SKELAXINSKELAXIN
    60793-136SKELAXINSKELAXIN
    80425-0084SkelaxinSkelaxin
    80425-0122SkelaxinSkelaxin
    0115-1745MetaxaloneMetaxalone
    0115-1748MetaxaloneMetaxalone
    0185-0448MetaxaloneMetaxalone
    0276-0508MetaxaloneMetaxalone
    0527-1435MetaxaloneMetaxalone
    0591-2341MetaxaloneMetaxalone
    0904-6831MetaxaloneMetaxalone
    10544-002MetaxaloneMetaxalone
    10544-144MetaxaloneMetaxalone
    21695-585MetaxaloneMetaxalone
    33261-724MetaxaloneMetaxalone
    35356-570MetaxaloneMetaxalone
    42254-040MetaxaloneMetaxalone
    42291-587MetaxaloneMetaxalone
    43063-239MetaxaloneMetaxalone
    43063-581MetaxaloneMetaxalone
    45865-942MetaxaloneMetaxalone
    45865-985MetaxaloneMetaxalone
    50090-1182MetaxaloneMetaxalone
    50090-3174MetaxaloneMetaxalone
    50090-3297MetaxaloneMetaxalone
    50090-3650MetaxaloneMetaxalone
    50090-3670MetaxaloneMetaxalone

    Trademark Results [SKELAXIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SKELAXIN
    SKELAXIN
    72111057 0715343 Live/Registered
    A. H. Robins Company, Incorporated
    1960-12-30
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