What is NDC 72189-645?

72189-645 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Direct_Rx. It has 3 package NDCs, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 72189-645 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-645Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0645Add 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
72189-645-30	7218906453072189064530	30 TABLET in 1 BOTTLE (72189-645-30)Marketed from Dec 8, 2025
72189-645-60	7218906456072189064560	60 TABLET in 1 BOTTLE (72189-645-60)Marketed from Dec 8, 2025
72189-645-90	7218906459072189064590	90 TABLET in 1 BOTTLE (72189-645-90)Marketed from Dec 8, 2025

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: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203695
Marketing start: Dec 8, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 72189-645_485b0bfc-d2a5-21dd-e063-6294a90a96d1SPL ID 485b0bfc-d2a5-21dd-e063-6294a90a96d1SPL set ID 45726fbc-3450-63f7-e063-6394a90a671aRxCUI 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

N472189064530 followed by a unit qualifier and the quantity

Package 72189-0645-30. 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 Jan 14, 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-645

What is NDC 72189-645?: 72189-645 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Direct_Rx. 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?: Direct_Rx, NDC labeler code 72189. 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	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
Metaxalone	Metaxalone 400 mg/1	TabletOral	CIPLA USA INC.	69097-998	69097-0998-07

All 63 Metaxalone NDCs

Other NDCs under ANDA 203695

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

FDA NDC Directory listings under ANDA 203695
Product	Strength	Form · route	Labeler	Product NDC
Metaxalone	Metaxalone 800 mg/1	TabletOral	Actavis Pharma, Inc.	0591-2341
Metaxalone	Metaxalone 800 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-093
Metaxalone	Metaxalone 800 mg/1	TabletOral	Bryant Ranch Prepack	63629-8014
Metaxalone	Metaxalone 800 mg/1	TabletOral	Doc Rx	69306-100
Metaxalone	Metaxalone 800 mg/1	TabletOral	Proficient Rx LP	71205-326
Metaxalone	Metaxalone 800 mg/1	TabletOral	Bryant Ranch Prepack	71335-0375
Metaxalone	Metaxalone 800 mg/1	TabletOral	Asclemed USA, Inc.	76420-898
Metaxalone	Metaxalone 800 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0131
Metaxalone	Metaxalone 800 mg/1	TabletOral	PHOENIX RX LLC	85509-2341
Metaxalone	Metaxalone 800 mg/1	TabletOral	Sportpharm LLC	85766-011