NDC 51021-333

Metaxall

Metaxalone

Metaxall is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sircle Laboratories, Llc. The primary component is Metaxalone.

• Product ID: 51021-333_3c99f58a-3185-4557-be23-0a1cdf0ce18c
• NDC: 51021-333
• Product Type: Human Prescription Drug
• Proprietary Name: Metaxall
• Generic Name: Metaxalone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-09-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203399
• Labeler Name: Sircle Laboratories, LLC
• Substance Name: METAXALONE
• Active Ingredient Strength: 800 mg/1
• Pharm Classes: Centrally-mediated Muscle Relaxation [PE]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 51021-333-60

60 TABLET in 1 BOTTLE, PLASTIC (51021-333-60)

• Marketing Start Date: 2015-09-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51021-333-30 [51021033330]

Metaxall TABLET

• Marketing Category: ANDA
• Application Number: ANDA203399
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-25
• Marketing End Date: 2019-08-14

NDC 51021-333-60 [51021033360]

Metaxall TABLET

• Marketing Category: ANDA
• Application Number: ANDA203399
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-25
• Marketing End Date: 2019-08-14

Drug Details

Active Ingredients

Ingredient	Strength
METAXALONE	800 mg/1

OpenFDA Data

• SPL SET ID: 22a8cbe9-3914-2881-e054-00144ff8d46c
• Manufacturer:
  • Sircle Laboratories, LLC
• UNII:
  • 1NMA9J598Y
• RxNorm Concept Unique ID - RxCUI:
  • 351254
  • 1720612

Pharmacological Class

• Centrally-mediated Muscle Relaxation [PE]

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

NDC	Brand Name	Generic Name
51021-333	Metaxall	Metaxall
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
10544-524	SKELAXIN	metaxalone
21695-123	Skelaxin	Metaxalone