Metaxalone NDC 42291-985

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-985Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0985Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42291-985-01	42291098501	100 TABLET in 1 BOTTLE (42291-985-01)Marketed from Mar 4, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Metaxalone
Generic name (nonproprietary): metaxalone
Active ingredients: Metaxalone — 800 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203399
Marketing start: Mar 4, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 42291-985_4d3bc865-2e42-28c2-e063-6394a90aec0aSPL ID 4d3bc865-2e42-28c2-e063-6394a90aec0aSPL set ID 4c3b2aa4-fe65-507c-e063-6394a90a7b00RxCUI 351254UNII 1NMA9J598Y
Pharmacologic class: Muscle Relaxant

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442291098501 followed by a unit qualifier and the quantity

Package 42291-0985-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 17, 2026.

Indications (excerpt from the label)

Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. Metaxalone is a muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203399

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203399
Product	Strength	Form · route	Labeler	Product NDC
Metaxalone	Metaxalone 800 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-553
Metaxalone	Metaxalone 800 mg/1	TabletOral	AvPAK	50268-530
Metaxalone	Metaxalone 800 mg/1	TabletOral	Proficient Rx LP	63187-490
Metaxalone	Metaxalone 800 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0084
Metaxalone	Metaxalone 800 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-553