NDC 55289-736

SKELAXIN

Metaxalone

SKELAXIN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Metaxalone.

Product ID55289-736_7c343a74-9250-0d28-e053-2991aa0a98f8
NDC55289-736
Product TypeHuman Prescription Drug
Proprietary NameSKELAXIN
Generic NameMetaxalone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2002-08-30
Marketing CategoryNDA / NDA
Application NumberNDA013217
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameMETAXALONE
Active Ingredient Strength800 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55289-736-10

10 TABLET in 1 BOTTLE, PLASTIC (55289-736-10)
Marketing Start Date2011-09-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-736-10 [55289073610]

SKELAXIN TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-06

NDC 55289-736-40 [55289073640]

SKELAXIN TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-06

NDC 55289-736-15 [55289073615]

SKELAXIN TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-08-30
Marketing End Date2017-08-14

NDC 55289-736-20 [55289073620]

SKELAXIN TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-06

NDC 55289-736-21 [55289073621]

SKELAXIN TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-06

NDC 55289-736-30 [55289073630]

SKELAXIN TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-06

Drug Details

Active Ingredients

IngredientStrength
METAXALONE800 mg/1

OpenFDA Data

SPL SET ID:eca7792e-c07b-4a42-9b2b-48a4366b77a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 352277
  • 351254
    • UPC Code
  • 0355289736158

    • 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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