Metaxalone

Product NDC: 65162-553
11-digit product format: 651620553
Labeler code: 65162
Product ID: 65162-553_5dbbcb1c-6935-4264-a95c-36d5555afc6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA203399
Marketing category: ANDA
Marketing start: 2013-05-31
Substance: METAXALONE
Active strength: 800 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Metaxalone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METAXALONE	800 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	1NMA9J598Y
Rxcui	351254

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-553-10	Metaxalone	100 in 1 BOTTLE	TABLET	100		12
65162-553-50	Metaxalone	500 in 1 BOTTLE	TABLET	500		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-553-10	EA - Each	65162-553	50f62890-6bd3-42d9-a06e-3920d90a9848	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METAXALONE TABLET [BLENHEIM PHARMACAL, INC.]	3
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METAXALONE TABLET [AMNEAL PHARMACEUTICALS, LLC]	2
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [PROFICIENT RX LP]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE (METAXALONE) TABLET [AVPAK]	1
METAXALONE	ACTIVE INGREDIENT	1NMA9J598Y	METAXALONE TABLET [NORTHWIND PHARMACEUTICALS]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [PROFICIENT RX LP]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE (METAXALONE) TABLET [AVPAK]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [NORTHWIND PHARMACEUTICALS]	1
METAXALONE	ACTIVE MOIETY	1NMA9J598Y	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	METAXALONE TABLET [PROFICIENT RX LP]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	METAXALONE (METAXALONE) TABLET [AVPAK]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METAXALONE TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METAXALONE (METAXALONE) TABLET [AVPAK]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METAXALONE (METAXALONE) TABLET [AVPAK]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METAXALONE TABLET [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METAXALONE TABLET [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METAXALONE (METAXALONE) TABLET [AVPAK]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METAXALONE TABLET [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METAXALONE (METAXALONE) TABLET [AVPAK]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METAXALONE (METAXALONE) TABLET [AVPAK]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METAXALONE TABLET [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METAXALONE TABLET [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METAXALONE (METAXALONE) TABLET [AVPAK]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METAXALONE (METAXALONE) TABLET [AVPAK]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METAXALONE TABLET [PROFICIENT RX LP]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METAXALONE (METAXALONE) TABLET [AVPAK]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METAXALONE TABLET [PROFICIENT RX LP]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METAXALONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METAXALONE (METAXALONE TABLET) TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-553	METAXALONE TABLET [AMNEAL PHARMACEUTICALS LLC]	11	Current NDC, Legacy NDC, 2 package rows	20240910_3aa9dba9-29b0-4520-a0f7-66d19d52c6bc.zip

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	3aa9dba9-29b0-4520-a0f7-66d19d52c6bc	12
351254	metaxalone 800 MG Oral Tablet	SCD	3aa9dba9-29b0-4520-a0f7-66d19d52c6bc	12
351254	metaxalone 800 MG Oral Tablet	PSN	b3279496-293e-7e1f-e053-2a95a90ab506	6
351254	metaxalone 800 MG Oral Tablet	PSN	9b21a974-6a5a-9efb-e9de-470363217126	6
351254	metaxalone 800 MG Oral Tablet	SCD	b3279496-293e-7e1f-e053-2a95a90ab506	6
351254	metaxalone 800 MG Oral Tablet	SCD	9b21a974-6a5a-9efb-e9de-470363217126	6
351254	metaxalone 800 MG Oral Tablet	PSN	fba1601d-3ac4-41cf-9548-35ec4994a95e	5
351254	metaxalone 800 MG Oral Tablet	SCD	fba1601d-3ac4-41cf-9548-35ec4994a95e	5
351254	metaxalone 800 MG Oral Tablet	PSN	4dee3f39-f735-329c-e054-00144ff8d46c	4
351254	metaxalone 800 MG Oral Tablet	SCD	4dee3f39-f735-329c-e054-00144ff8d46c	4
351254	metaxalone 800 MG Oral Tablet	PSN	117c6190-77a2-2036-e054-00144ff8d46c	3
351254	metaxalone 800 MG Oral Tablet	SCD	117c6190-77a2-2036-e054-00144ff8d46c	3
351254	metaxalone 800 MG Oral Tablet	PSN	4c3b2aa4-fe65-507c-e063-6394a90a7b00	2
351254	metaxalone 800 MG Oral Tablet	PSN	e8643c67-c531-4a4f-931d-0e3c91cfc0c8	2
351254	metaxalone 800 MG Oral Tablet	SCD	4c3b2aa4-fe65-507c-e063-6394a90a7b00	2
351254	metaxalone 800 MG Oral Tablet	SCD	e8643c67-c531-4a4f-931d-0e3c91cfc0c8	2
351254	metaxalone 800 MG Oral Tablet	PSN	5311bdb3-37a7-48d8-a5bb-5765b3d43fbc	1
351254	metaxalone 800 MG Oral Tablet	PSN	4c3ae824-48a9-fd91-e063-6394a90a9a54	1
351254	metaxalone 800 MG Oral Tablet	SCD	5311bdb3-37a7-48d8-a5bb-5765b3d43fbc	1
351254	metaxalone 800 MG Oral Tablet	SCD	4c3ae824-48a9-fd91-e063-6394a90a9a54	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-553-10	65162055310	100 TABLET in 1 BOTTLE (65162-553-10)	100 tablet	2013-05-31	0000-00-00	No	No	Current
65162-553-50	65162055350	500 TABLET in 1 BOTTLE (65162-553-50)	500 tablet	2013-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metaxalone	AvKARE	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	2
Metaxalone	AvKARE	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	1
Metaxalone Tablets	AvPAK	2025-11-26	HUMAN PRESCRIPTION DRUG LABEL	6
Metaxalone	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	12
Metaxalone Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Metaxalone Tablets	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	5
Metaxalone - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	4
METAXALONE- metaxalone tablet	Direct RX	2019-10-10	HUMAN PRESCRIPTION DRUG LABEL	2
Metaxalone Tablets	Blenheim Pharmacal, Inc.	2015-09-02	HUMAN PRESCRIPTION DRUG LABEL	3
Metaxalone - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2014-06-03	HUMAN PRESCRIPTION DRUG LABEL	1
Metaxalone Tablets	Aidarex Pharmaceuticals LLC	2014-01-13	HUMAN PRESCRIPTION DRUG LABEL	1

Metaxalone

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#