NDC 35356-570

Metaxalone

Metaxalone

Metaxalone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc. The primary component is Metaxalone.

Product ID35356-570_f5b13d71-cb1f-470d-b0b9-36f0b711e566
NDC35356-570
Product TypeHuman Prescription Drug
Proprietary NameMetaxalone
Generic NameMetaxalone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-12-06
Marketing CategoryNDA / NDA
Application NumberNDA013217
Labeler NameLake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Substance NameMETAXALONE
Active Ingredient Strength800 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 35356-570-60

60 TABLET in 1 BOTTLE (35356-570-60)
Marketing Start Date2011-12-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-570-30 [35356057030]

Metaxalone TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-06
Marketing End Date2017-06-01

NDC 35356-570-60 [35356057060]

Metaxalone TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-06
Marketing End Date2017-06-01

NDC 35356-570-90 [35356057090]

Metaxalone TABLET
Marketing CategoryNDA
Application NumberNDA013217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-06
Marketing End Date2017-06-01

Drug Details

Active Ingredients

IngredientStrength
METAXALONE800 mg/1

OpenFDA Data

SPL SET ID:ac32ec3b-29f3-4008-8995-9c468bbd4318
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351254

    • Pharmacological Class

    • Centrally-mediated Muscle Relaxation [PE]

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

    NDCBrand NameGeneric Name
    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
    68001-004MetaxaloneMetaxalone
    68084-135MetaxaloneMetaxalone
    68151-4668MetaxaloneMetaxalone
    68258-7100MetaxaloneMetaxalone
    68387-108MetaxaloneMetaxalone
    68788-7073MetaxaloneMetaxalone
    68788-7018MetaxaloneMetaxalone
    68788-6466MetaxaloneMetaxalone
    68788-9896MetaxaloneMetaxalone
    68788-9277MetaxaloneMetaxalone
    70332-330MetaxaloneMetaxalone
    70518-0818MetaxaloneMetaxalone
    70518-0771MetaxaloneMetaxalone
    70518-1161MetaxaloneMetaxalone
    70934-160MetaxaloneMetaxalone
    71335-0099MetaxaloneMetaxalone
    71335-0186MetaxaloneMetaxalone
    71205-016MetaxaloneMetaxalone
    71335-0375MetaxaloneMetaxalone
    71335-0958MetaxaloneMetaxalone
    50228-323MetaxaloneMetaxalone
    50436-0448MetaxaloneMetaxalone
    50268-530MetaxaloneMetaxalone
    50436-3024MetaxaloneMetaxalone
    51655-162MetaxaloneMetaxalone
    51655-167MetaxaloneMetaxalone
    51655-163MetaxaloneMetaxalone
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