What is NDC 0115-1745?

0115-1745 is the product NDC for Metaxalone, Metaxalone 400 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 0115-1745 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1745Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1745Add 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
0115-1745-01	0011517450100115174501	100 TABLET in 1 BOTTLE (0115-1745-01)Marketed from May 26, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 400 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040486
Marketing start: May 26, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 0115-1745_3bbe28a7-6fc1-4bd0-aea7-f64a98878335SPL ID 3bbe28a7-6fc1-4bd0-aea7-f64a98878335SPL set ID de3448df-4ca1-44ec-bad1-486549cddf64RxCUI 197935UNII 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

N400115174501 followed by a unit qualifier and the quantity

Package 00115-1745-01. 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 Aug 30, 2024.

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. Metaxalone is a muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-1745

What is NDC 0115-1745?: 0115-1745 is the product NDC for Metaxalone, Metaxalone 400 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, 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 0115. 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