NDC 53746-553

Metaxalone

Metaxalone

Metaxalone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Metaxalone.

Product ID53746-553_07594db6-71e9-4703-8380-2a787b6324a9
NDC53746-553
Product TypeHuman Prescription Drug
Proprietary NameMetaxalone
Generic NameMetaxalone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA203399
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameMETAXALONE
Active Ingredient Strength800 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53746-553-01

100 TABLET in 1 BOTTLE (53746-553-01)
Marketing Start Date2013-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53746-553-01 [53746055301]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA203399
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-31

NDC 53746-553-05 [53746055305]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA203399
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-31

NDC 53746-553-30 [53746055330]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA203399
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-31

Drug Details

Active Ingredients

IngredientStrength
METAXALONE800 mg/1

OpenFDA Data

SPL SET ID:f06f2b96-3684-483c-89f7-6c9201fd4664
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351254
    • UPC Code
  • 0353746553300

    • 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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