Metaxalone NDC 63187-490

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-490Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0490Add 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
63187-490-10	63187049010	10 TABLET in 1 BOTTLE (63187-490-10)Marketed from Feb 2, 2015
63187-490-30	63187049030	30 TABLET in 1 BOTTLE (63187-490-30)Marketed from Feb 2, 2015
63187-490-60	63187049060	60 TABLET in 1 BOTTLE (63187-490-60)Marketed from Feb 2, 2015
63187-490-90	63187049090	90 TABLET in 1 BOTTLE (63187-490-90)Marketed from Feb 2, 2015

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: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203399
Marketing start: May 31, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 63187-490_37b601ca-6b00-44c1-8b4c-f9e007190df0SPL ID 37b601ca-6b00-44c1-8b4c-f9e007190df0SPL set ID fba1601d-3ac4-41cf-9548-35ec4994a95eRxCUI 351254UNII 1NMA9J598YUPC 0363187490300

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

N463187049010 followed by a unit qualifier and the quantity

Package 63187-0490-10. 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 Oct 1, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.

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	AvKARE	42291-985
Metaxalone	Metaxalone 800 mg/1	TabletOral	AvKARE	42291-985
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