What is NDC 80425-0084?

80425-0084 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Metaxalone?

62 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metaxalone NDC 80425-0084 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0084Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0084Add 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
80425-0084-2	8042500840280425008402	60 TABLET in 1 BOTTLE (80425-0084-2)Marketed from May 31, 2013
80425-0084-3	8042500840380425008403	90 TABLET in 1 BOTTLE (80425-0084-3)Marketed from May 31, 2013

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Advanced Rx of Tennessee, LLCNDC labeler code 80425
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 80425-0084_2a990578-5a3d-aeda-e063-6294a90af6fbSPL ID 2a990578-5a3d-aeda-e063-6294a90af6fbSPL set ID b3279496-293e-7e1f-e053-2a95a90ab506RxCUI 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

N480425008402 followed by a unit qualifier and the quantity

Package 80425-0084-02. 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 Dec 31, 2024.

Indications (excerpt from the label)

Indications and Usage Section 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)

About NDC 80425-0084

What is NDC 80425-0084?: 80425-0084 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metaxalone.
What is the active ingredient?: Metaxalone.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metaxalone?: 62 other product NDCs are listed under this name. See all Metaxalone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Metaxalone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metaxalone	Metaxalone 400 mg/1	TabletOral	Blue Heron Pharmaceuticals, LLC	85622-950	85622-0950-10
Metaxalone	Metaxalone 800 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4168	68788-4168-0168788-4168-0368788-4168-06+2 more
Metaxalone	Metaxalone 800 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0580	80425-0580-0180425-0580-0280425-0580-03
Metaxalone	Metaxalone 800 mg/1	TabletOral	AvKARE	42291-985	42291-0985-50
Metaxalone	Metaxalone 800 mg/1	TabletOral	AvKARE	42291-985	42291-0985-01
Metaxalone	Metaxalone 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-4559	70518-4559-0070518-4559-01
Metaxalone	Metaxalone 800 mg/1	TabletOral	Direct_Rx	72189-645	72189-0645-3072189-0645-6072189-0645-90
Metaxalone	Metaxalone 800 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0524	80425-0524-0180425-0524-0280425-0524-03
Metaxalone	Metaxalone 640 mg/1	TabletOral	INA Pharmaceutics Inc	74157-018	74157-0018-60
Metaxalone	Metaxalone 800 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8678	68788-8678-0168788-8678-09

All 63 Metaxalone NDCs

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	AvKARE	42291-985
Metaxalone	Metaxalone 800 mg/1	TabletOral	AvPAK	50268-530
Metaxalone	Metaxalone 800 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-553
Metaxalone	Metaxalone 800 mg/1	TabletOral	Proficient Rx LP	63187-490
Metaxalone	Metaxalone 800 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-553