NDC 61919-832

METAXALONE

Metaxalone

METAXALONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Metaxalone.

Product ID61919-832_87fdca26-e05b-053b-e053-2995a90acfa2
NDC61919-832
Product TypeHuman Prescription Drug
Proprietary NameMETAXALONE
Generic NameMetaxalone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-05-03
Marketing CategoryANDA / ANDA
Application NumberANDA204770
Labeler NameDIRECT RX
Substance NameMETAXALONE
Active Ingredient Strength800 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-832-90

90 TABLET in 1 BOTTLE (61919-832-90)
Marketing Start Date2019-05-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-832-72 [61919083272]

METAXALONE TABLET
Marketing CategoryANDA
Application NumberANDA204770
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-06

NDC 61919-832-30 [61919083230]

METAXALONE TABLET
Marketing CategoryANDA
Application NumberANDA204770
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-26

NDC 61919-832-90 [61919083290]

METAXALONE TABLET
Marketing CategoryANDA
Application NumberANDA204770
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-03

NDC 61919-832-60 [61919083260]

METAXALONE TABLET
Marketing CategoryANDA
Application NumberANDA204770
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-29

Drug Details

Active Ingredients

IngredientStrength
METAXALONE800 mg/1

Pharmacological Class

  • Centrally-mediated Muscle Relaxation [PE]
  • 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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