NDC 60760-289

Metaxalone

Metaxalone

Metaxalone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by St. Mary's Medical Park Pharmacy. The primary component is Metaxalone.

Product ID60760-289_a2f1a43d-9fe1-69bc-e053-2a95a90ae5af
NDC60760-289
Product TypeHuman Prescription Drug
Proprietary NameMetaxalone
Generic NameMetaxalone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA204770
Labeler NameSt. Mary's Medical Park Pharmacy
Substance NameMETAXALONE
Active Ingredient Strength800 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 60760-289-06

6 TABLET in 1 BOTTLE, PLASTIC (60760-289-06)
Marketing Start Date2020-06-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60760-289-20 [60760028920]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA204770
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-31

NDC 60760-289-30 [60760028930]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA204770
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-31

NDC 60760-289-60 [60760028960]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA204770
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-24

NDC 60760-289-90 [60760028990]

Metaxalone TABLET
Marketing CategoryANDA
Application NumberANDA204770
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-31

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
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.