NDC 68788-7499

Metaxalone

Metaxalone

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

Product ID68788-7499_3f3a4ca6-999e-4d1d-8a3e-796bdc4ef2fa
NDC68788-7499
Product TypeHuman Prescription Drug
Proprietary NameMetaxalone
Generic NameMetaxalone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-09-24
Marketing CategoryANDA / ANDA
Application NumberANDA208774
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameMETAXALONE
Active Ingredient Strength800 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68788-7499-0

15 TABLET in 1 BOTTLE (68788-7499-0)
Marketing Start Date2019-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7499-0 [68788749900]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA208774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7499-1 [68788749901]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA208774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7499-9 [68788749909]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA208774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7499-2 [68788749902]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA208774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7499-6 [68788749906]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA208774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7499-3 [68788749903]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA208774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

Drug Details

Active Ingredients

IngredientStrength
METAXALONE800 mg/1

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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