NDC 50228-474

Metaxalone

Metaxalone

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

Product ID50228-474_1a9a8e17-2320-4a91-b75f-5868866db2c4
NDC50228-474
Product TypeHuman Prescription Drug
Proprietary NameMetaxalone
Generic NameMetaxalone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA207466
Labeler NameScieGen Pharmaceuticals, Inc.
Substance NameMETAXALONE
Active Ingredient Strength400 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50228-474-10

1000 TABLET in 1 BOTTLE (50228-474-10)
Marketing Start Date2020-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50228-474-10 [50228047410]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA207466
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

NDC 50228-474-30 [50228047430]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA207466
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
METAXALONE400 mg/1

OpenFDA Data

SPL SET ID:1cef46bb-e590-4a58-82e0-7cf1fc3836a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197935
    • UPC Code
  • 0350228474108
  • 0350228474306

    • 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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