Metaxalone

Product NDC: 87450-101
11-digit product format: 874500101
Labeler code: 87450
Product ID: 87450-101_850ec0a9-4944-4e15-bbb9-e435e57bb269
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: Highmark Pharma LLC
Application: ANDA207466
Marketing category: ANDA
Marketing start: 2021-11-01
Substance: METAXALONE
Active strength: 400 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
87450-101-10	Metaxalone	100 in 1 BOTTLE	TABLET	100		1

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197935	metaxalone 400 MG Oral Tablet	PSN	834be129-cfb5-4420-b660-025833376b3e	1
197935	metaxalone 400 MG Oral Tablet	SCD	834be129-cfb5-4420-b660-025833376b3e	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87450-101-10	87450010110	100 TABLET in 1 BOTTLE (87450-101-10)	100 tablet	2026-04-26	No	No	Historical