What is NDC 80425-0122?

80425-0122 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy 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 80425-0122 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0122Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0122Add 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
80425-0122-1	8042501220180425012201	30 TABLET in 1 BOTTLE (80425-0122-1)Marketed from Nov 22, 2016
80425-0122-2	8042501220280425012202	60 TABLET in 1 BOTTLE (80425-0122-2)Marketed from Nov 22, 2016
80425-0122-3	8042501220380425012203	90 TABLET in 1 BOTTLE (80425-0122-3)Marketed from Nov 22, 2016

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 Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204770
Marketing start: Nov 22, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 80425-0122_2a99aae5-c903-7940-e063-6294a90a4146SPL ID 2a99aae5-c903-7940-e063-6294a90a4146SPL set ID b713a0f2-d47a-0ae7-e053-2995a90a5b85RxCUI 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

N480425012201 followed by a unit qualifier and the quantity

Package 80425-0122-01. 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 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 80425-0122

What is NDC 80425-0122?: 80425-0122 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 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 Pharmacy 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 204770

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

FDA NDC Directory listings under ANDA 204770
Product	Strength	Form · route	Labeler	Product NDC
Metaxalone	Metaxalone 800 mg/1	TabletOral	Bryant Ranch Prepack	72162-1083
Metaxalone	Metaxalone 800 mg/1	TabletOral	Bryant Ranch Prepack	63629-2097
Metaxalone	Metaxalone 800 mg/1	TabletOral	Asclemed USA, Inc.	76420-232
Metaxalone	Metaxalone 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-0771
Metaxalone	Metaxalone 800 mg/1	TabletOral	Lannett Company, Inc.	0527-1435
Metaxalone	Metaxalone 800 mg/1	TabletOral	Bryant Ranch Prepack	71335-2066
Metaxalone	Metaxalone 800 mg/1	TabletOral	A-S Medication Solutions	50090-3650
Metaxalone	Metaxalone 800 mg/1	TabletOral	A-S Medication Solutions	50090-3670
Metaxalone	Metaxalone 800 mg/1	TabletOral	Bryant Ranch Prepack	71335-0958
Metaxalone	Metaxalone 800 mg/1	TabletOral	PHOENIX RX LLC	85509-1435
Metaxalone	Metaxalone 800 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7675
Metaxalone	Metaxalone 800 mg/1	TabletOral	DIRECT RX	61919-832
Metaxalone	Metaxalone 800 mg/1	TabletOral	DIRECT RX	61919-832
Metaxalone	Metaxalone 800 mg/1	TabletOral	Direct_Rx	61919-832
Metaxalone	Metaxalone 800 mg/1	TabletOral	Direct_Rx	61919-832
Metaxalone	Metaxalone 800 mg/1	TabletOral	Proficient Rx LP	71205-426
Metaxalone	Metaxalone 800 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-289
Metaxalone	Metaxalone 800 mg/1	TabletOral	Northwind Health Company, LLC	51655-792
Metaxalone	Metaxalone 800 mg/1	TabletOral	Sportpharm LLC	85766-143
Metaxalone	Metaxalone 800 mg/1	TabletOral	Quality Care Products, LLC	55700-494

Showing 20 of 21.