Metaxalone

Product NDC: 72789-028
11-digit product format: 727890028
Labeler code: 72789
Product ID: 72789-028_2d58ab65-a0e3-e2a2-e063-6294a90a0e4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metaxalone
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA207466
Marketing category: ANDA
Marketing start: 2017-08-31
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

openFDA Listing Details

Product ID: 72789-028_2d58ab65-a0e3-e2a2-e063-6294a90a0e4a
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Metaxalone
Generic name: Metaxalone
Dosage form: TABLET
Route: ORAL
Marketing start: 2017-08-31
Marketing category: ANDA
Application number: ANDA207466
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE]; Muscle Relaxant [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
METAXALONE	800 mg/1

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

Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-028-15	72789002815	15 TABLET in 1 BOTTLE, PLASTIC (72789-028-15)	15 tablet	2019-11-19	0000-00-00	No	No	Current
72789-028-30	72789002830	30 TABLET in 1 BOTTLE, PLASTIC (72789-028-30)	30 tablet	2019-11-11	0000-00-00	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Metaxalone	PD-Rx Pharmaceuticals, Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	13