What is NDC 68788-8678?

68788-8678 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 68788-8678 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8678Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8678Add 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
68788-8678-1	6878886780168788867801	100 TABLET in 1 BOTTLE (68788-8678-1)Marketed from May 28, 2024
68788-8678-9	6878886780968788867809	90 TABLET in 1 BOTTLE (68788-8678-9)Marketed from May 28, 2024

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: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207466
Marketing start: May 28, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 68788-8678_c03f5c2f-33f8-439f-b81a-6710388cd872SPL ID c03f5c2f-33f8-439f-b81a-6710388cd872SPL set ID 8aa84e64-0075-4f22-a576-da085f32d56cRxCUI 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

N468788867801 followed by a unit qualifier and the quantity

Package 68788-8678-01. 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 Jun 17, 2026.

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)

About NDC 68788-8678

What is NDC 68788-8678?: 68788-8678 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 400 mg/1	TabletOral	CIPLA USA INC.	69097-998	69097-0998-07

All 63 Metaxalone NDCs

Other NDCs under ANDA 207466

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

FDA NDC Directory listings under ANDA 207466
Product	Strength	Form · route	Labeler	Product NDC
Metaxalone	Metaxalone 400 mg/1	TabletOral	Misemer Pharmaceuticals, Inc.	0276-0508
Metaxalone	Metaxalone 800 mg/1	TabletOral	Major Pharmaceuticals	0904-6831
Metaxalone	Metaxalone 800 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-323
Metaxalone	Metaxalone 400 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-474
Metaxalone	Metaxalone 800 mg/1	TabletOral	Northwind Health Company, LLC	51655-171
Metaxalone	Metaxalone 800 mg/1	TabletOral	Dr. Reddys Laboratories Limited	55111-650
Metaxalone	Metaxalone 800 mg/1	TabletOral	American Health Packaging	60687-663
Metaxalone	Metaxalone 800 mg/1	TabletOral	BluePoint Laboratories	68001-485
Metaxalone	Metaxalone 800 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4168
Metaxalone	Metaxalone 400 mg/1	TabletOral	CIPLA USA INC.	69097-998
Metaxalone	Metaxalone 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-4559
Metaxalone	Metaxalone 800 mg/1	TabletOral	Proficient Rx LP	71205-016
Metaxalone	Metaxalone 800 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-028
Metaxalone	Metaxalone 800 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-592
Metaxalone	Metaxalone 800 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0524
Metaxalone	Metaxalone 800 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0580
Metaxalone	Metaxalone 400 mg/1	TabletOral	Blue Heron Pharmaceuticals, LLC	85622-950
Metaxalone	Metaxalone 400 mg/1	TabletOral	Highmark Pharma LLC	87450-101