What is NDC 53746-553?

53746-553 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 53746-553 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-553Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0553Add 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
53746-553-01	5374605530153746055301	100 TABLET in 1 BOTTLE (53746-553-01)Marketed from May 31, 2013
53746-553-05	5374605530553746055305	500 TABLET in 1 BOTTLE (53746-553-05)Marketed from May 31, 2013
53746-553-30	5374605533053746055330	30 TABLET in 1 BOTTLE (53746-553-30)Marketed from May 31, 2013

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: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203399
Marketing start: May 31, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 53746-553_b3ba9f93-52d6-4287-9e28-92059e0bf18bSPL ID b3ba9f93-52d6-4287-9e28-92059e0bf18bSPL set ID f06f2b96-3684-483c-89f7-6c9201fd4664RxCUI 351254UNII 1NMA9J598YUPC 0353746553300

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

N453746055301 followed by a unit qualifier and the quantity

Package 53746-0553-01. 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 Jan 11, 2023.

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 53746-553

What is NDC 53746-553?: 53746-553 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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	Proficient Rx LP	63187-490
Metaxalone	Metaxalone 800 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-553
Metaxalone	Metaxalone 800 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0084