Metaxalone

Product NDC: 64720-321
11-digit product format: 647200321
Labeler code: 64720
Product ID: 64720-321_ae0896e9-ce19-4eda-8cda-3ceab9d674e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: CorePharma, LLC
Application: NDA013217
Marketing category: NDA
Marketing start: 2007-11-01
Marketing end: 2020-04-01
Substance: METAXALONE
Active strength: 800 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe1c2a6-5488-f909-3872-734054eb745a	Product name	5	20181231
776ba7f6-e5b0-442b-bd42-1fdfdfd821a4	Product name	1	20150615
68c52498-c9cb-48ab-a792-a4876149361e	Product name	1	20150409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64720-321-10	EA - Each	64720-321	74f9cb31-1f75-4fb0-8dcb-d81e89946cdb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC]	5
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC]	5
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC]	5
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC]	5
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [CARILION MATERIALS MANAGEMENT]	2
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	2
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [STAT RX USA LLC]	2
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [CARILION MATERIALS MANAGEMENT]	2
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	2
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [STAT RX USA LLC]	2
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE TABLET [CARILION MATERIALS MANAGEMENT]	2
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE TABLET [STAT RX USA LLC]	2
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	2
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	2
CALCIUM ALGINATE	INACTIVE INGREDIENT	8P20S56HZI	METAXALONE TABLET [STAT RX USA LLC]	2
CALCIUM ALGINATE	INACTIVE INGREDIENT	8P20S56HZI	METAXALONE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE TABLET [STAT RX USA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE TABLET [STAT RX USA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE TABLET [CARILION MATERIALS MANAGEMENT]	2
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [DIRECT RX]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [NORTHWIND PHARMACEUTICALS]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [STAT RX USA LLC]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [REBEL DISTRIBUTORS CORP]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [REBEL DISTRIBUTORS CORP]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [STAT RX USA LLC]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [DIRECT RX]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [NORTHWIND PHARMACEUTICALS]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.]	1
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE TABLET [STAT RX USA LLC]	1
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE TABLET [DIRECT RX]	1
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	METAXALONE TABLET [REBEL DISTRIBUTORS CORP]	1
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	METAXALONE TABLET [REBEL DISTRIBUTORS CORP]	1
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	METAXALONE TABLET [STAT RX USA LLC]	1
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.]	1
CALCIUM ALGINATE	INACTIVE INGREDIENT	8P20S56HZI	METAXALONE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METAXALONE TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METAXALONE TABLET [REBEL DISTRIBUTORS CORP]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1NMA9J598Y	METAXALONE	1665-48-1	METAXALONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351254	metaxalone 800 MG Oral Tablet	PSN	d8684144-6c2d-4664-943a-2d3d2b46b1fc	5
352277	Skelaxin 800 MG Oral Tablet	PSN	d8684144-6c2d-4664-943a-2d3d2b46b1fc	5
352277	metaxalone 800 MG Oral Tablet [Skelaxin]	SBD	d8684144-6c2d-4664-943a-2d3d2b46b1fc	5
351254	metaxalone 800 MG Oral Tablet	SCD	d8684144-6c2d-4664-943a-2d3d2b46b1fc	5
352277	Skelaxin 800 MG Oral Tablet	SY	d8684144-6c2d-4664-943a-2d3d2b46b1fc	5
351254	metaxalone 800 MG Oral Tablet	PSN	61fc1a6a-ecfd-4467-b172-a11bebbc32d3	3
351254	metaxalone 800 MG Oral Tablet	SCD	61fc1a6a-ecfd-4467-b172-a11bebbc32d3	3
351254	metaxalone 800 MG Oral Tablet	PSN	f001063b-6577-4b48-899c-b05684b5e2b1	2
351254	metaxalone 800 MG Oral Tablet	PSN	9b22176d-95af-46d6-b02b-6a45ccb115ec	2
351254	metaxalone 800 MG Oral Tablet	PSN	b2f5989a-deb8-4437-93a5-9277c00a3183	2
351254	metaxalone 800 MG Oral Tablet	SCD	f001063b-6577-4b48-899c-b05684b5e2b1	2
351254	metaxalone 800 MG Oral Tablet	SCD	9b22176d-95af-46d6-b02b-6a45ccb115ec	2
351254	metaxalone 800 MG Oral Tablet	SCD	b2f5989a-deb8-4437-93a5-9277c00a3183	2
351254	metaxalone 800 MG Oral Tablet	PSN	b28a2d3c-69ca-4c97-915b-41135b9b5bc0	1
351254	metaxalone 800 MG Oral Tablet	PSN	bcf9b39a-aa68-4f07-accb-9e9287c63068	1
351254	metaxalone 800 MG Oral Tablet	PSN	0755d115-dbf4-44ac-a02f-4d8a013902e3	1
351254	metaxalone 800 MG Oral Tablet	PSN	83cfbe48-4b69-445a-9c13-742ea345830e	1
351254	metaxalone 800 MG Oral Tablet	PSN	1c410d74-2c12-4a6b-854e-8a03b5bf2fbf	1
351254	metaxalone 800 MG Oral Tablet	SCD	bcf9b39a-aa68-4f07-accb-9e9287c63068	1
351254	metaxalone 800 MG Oral Tablet	SCD	b28a2d3c-69ca-4c97-915b-41135b9b5bc0	1
351254	metaxalone 800 MG Oral Tablet	SCD	83cfbe48-4b69-445a-9c13-742ea345830e	1
351254	metaxalone 800 MG Oral Tablet	SCD	1c410d74-2c12-4a6b-854e-8a03b5bf2fbf	1
351254	metaxalone 800 MG Oral Tablet	SCD	0755d115-dbf4-44ac-a02f-4d8a013902e3	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METAXALONE	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Metaxalone - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2014-06-03	HUMAN PRESCRIPTION DRUG LABEL	1
Metaxalone Tablets 800 mg	STAT Rx USA LLC \| PSS World Medical Inc.	2012-09-28	HUMAN PRESCRIPTION DRUG LABEL	2
METAXALONE TABLETS 800 mg	STAT Rx USA LLC \| PSS World Medical Inc.	2012-02-27	HUMAN PRESCRIPTION DRUG LABEL	1
Metaxalone Tablets 800 mg	Carilion Materials Management	2012-02-16	HUMAN PRESCRIPTION DRUG LABEL	2
METAXALONE TABLETS 800 mg	Rebel Distributors Corp	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	1
METAXALONE TABLETS 800 mg	Dispensing Solutions, Inc.	2011-09-22	HUMAN PRESCRIPTION DRUG LABEL	1
METAXALONE TABLETS 800 mg	H.J. Harkins Company, Inc. \| Corepharma LLC.	2011-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
METAXALONE TABLETS 800 mg	Blenheim Pharmacal, Inc.	2011-06-06	HUMAN PRESCRIPTION DRUG LABEL	2
Skelaxin - Preferred Pharmaceuticals, Inc	Preferred Pharmaceuticals, Inc	2011-05-03	HUMAN PRESCRIPTION DRUG LABEL	5
Metaxalone Tablets, 800 mg	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-09-27	HUMAN PRESCRIPTION DRUG LABEL	1

Metaxalone

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#