NDC 68788-7018

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 ID: 68788-7018_3894a4ec-6872-43b5-8112-2294b9302614
• NDC: 68788-7018
• Product Type: Human Prescription Drug
• Proprietary Name: Metaxalone
• Generic Name: Metaxalone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203695
• Labeler Name: Preferred Pharmaceuticals Inc.
• Substance Name: METAXALONE
• Active Ingredient Strength: 800 mg/1
• Pharm Classes: Centrally-mediated Muscle Relaxation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68788-7018-0

100 TABLET in 1 BOTTLE (68788-7018-0)

• Marketing Start Date: 2017-10-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-7018-0 [68788701800]

Metaxalone TABLET

• Marketing Category: ANDA
• Application Number: ANDA203695
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-11

NDC 68788-7018-6 [68788701806]

Metaxalone TABLET

• Marketing Category: ANDA
• Application Number: ANDA203695
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-11

NDC 68788-7018-2 [68788701802]

Metaxalone TABLET

• Marketing Category: ANDA
• Application Number: ANDA203695
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-11

NDC 68788-7018-1 [68788701801]

Metaxalone TABLET

• Marketing Category: ANDA
• Application Number: ANDA203695
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-11

NDC 68788-7018-3 [68788701803]

Metaxalone TABLET

• Marketing Category: ANDA
• Application Number: ANDA203695
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-11

Drug Details

Active Ingredients

Ingredient	Strength
METAXALONE	800 mg/1

OpenFDA Data

• SPL SET ID: c0882edb-e2ad-470e-b26d-3c83b657abf9
• Manufacturer:
  • Preferred Pharmaceuticals Inc.
• UNII:
  • 1NMA9J598Y
• RxNorm Concept Unique ID - RxCUI:
  • 351254

Pharmacological Class

• Centrally-mediated Muscle Relaxation [PE]

NDC Crossover Matching brand name "Metaxalone" or generic name "Metaxalone"

NDC	Brand Name	Generic Name
0115-1745	Metaxalone	Metaxalone
0115-1748	Metaxalone	Metaxalone
0185-0448	Metaxalone	Metaxalone
0276-0508	Metaxalone	Metaxalone
0527-1435	Metaxalone	Metaxalone
0591-2341	Metaxalone	Metaxalone
0904-6831	Metaxalone	Metaxalone
10544-002	Metaxalone	Metaxalone
10544-144	Metaxalone	Metaxalone
21695-585	Metaxalone	Metaxalone
33261-724	Metaxalone	Metaxalone
35356-570	Metaxalone	Metaxalone
42254-040	Metaxalone	Metaxalone
42291-587	Metaxalone	Metaxalone
43063-239	Metaxalone	Metaxalone
43063-581	Metaxalone	Metaxalone
45865-942	Metaxalone	Metaxalone
45865-985	Metaxalone	Metaxalone
50090-1182	Metaxalone	Metaxalone
50090-3174	Metaxalone	Metaxalone
50090-3297	Metaxalone	Metaxalone
50090-3650	Metaxalone	Metaxalone
50090-3670	Metaxalone	Metaxalone
68001-004	Metaxalone	Metaxalone
68084-135	Metaxalone	Metaxalone
68151-4668	Metaxalone	Metaxalone
68258-7100	Metaxalone	Metaxalone
68387-108	Metaxalone	Metaxalone
68788-7073	Metaxalone	Metaxalone
68788-7018	Metaxalone	Metaxalone
68788-6466	Metaxalone	Metaxalone
68788-9896	Metaxalone	Metaxalone
68788-9277	Metaxalone	Metaxalone
70332-330	Metaxalone	Metaxalone
70518-0818	Metaxalone	Metaxalone
70518-0771	Metaxalone	Metaxalone
70518-1161	Metaxalone	Metaxalone
70934-160	Metaxalone	Metaxalone
71335-0099	Metaxalone	Metaxalone
71335-0186	Metaxalone	Metaxalone
71205-016	Metaxalone	Metaxalone
71335-0375	Metaxalone	Metaxalone
71335-0958	Metaxalone	Metaxalone
50228-323	Metaxalone	Metaxalone
50436-0448	Metaxalone	Metaxalone
50268-530	Metaxalone	Metaxalone
50436-3024	Metaxalone	Metaxalone
51655-162	Metaxalone	Metaxalone
51655-167	Metaxalone	Metaxalone
51655-163	Metaxalone	Metaxalone