NDC codes

FDA NDC Directory
Product NDC (as listed)85509-2341Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85509-2341Add 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 NDC11-digit (billing)PackageCopy
85509-2341-18550923410185509234101100 TABLET in 1 BOTTLE (85509-2341-1)Marketed from Jul 31, 2025
85509-2341-28550923410285509234102120 TABLET in 1 BOTTLE (85509-2341-2)Marketed from Jul 31, 2025
85509-2341-3855092341038550923410330 TABLET in 1 BOTTLE (85509-2341-3)Marketed from Jul 31, 2025
85509-2341-6855092341068550923410660 TABLET in 1 BOTTLE (85509-2341-6)Marketed from Jul 31, 2025
85509-2341-9855092341098550923410990 TABLET in 1 BOTTLE (85509-2341-9)Marketed from Jul 31, 2025

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
PHOENIX RX LLCNDC labeler code 85509
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203695
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 85509-2341_41ae7309-4967-b721-e063-6294a90abf2cSPL ID 41ae7309-4967-b721-e063-6294a90abf2cSPL set ID 3a7c8b4d-7add-cb31-e063-6294a90a37f8RxCUI 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

N485509234101 followed by a unit qualifier and the quantity

Package 85509-2341-01. 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 .

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 tablets are 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 85509-2341

What is NDC 85509-2341?
85509-2341 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by PHOENIX RX LLC. It has 5 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?
PHOENIX RX LLC, NDC labeler code 85509. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MetaxaloneMetaxalone 400 mg/1TabletOralBlue Heron Pharmaceuticals, LLC85622-95085622-0950-10
MetaxaloneMetaxalone 800 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-416868788-4168-0168788-4168-0368788-4168-06+2 more
MetaxaloneMetaxalone 800 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-058080425-0580-0180425-0580-0280425-0580-03
MetaxaloneMetaxalone 800 mg/1TabletOralAvKARE42291-98542291-0985-50
MetaxaloneMetaxalone 800 mg/1TabletOralAvKARE42291-98542291-0985-01
MetaxaloneMetaxalone 800 mg/1TabletOralREMEDYREPACK INC.70518-455970518-4559-0070518-4559-01
MetaxaloneMetaxalone 800 mg/1TabletOralDirect_Rx72189-64572189-0645-3072189-0645-6072189-0645-90
MetaxaloneMetaxalone 800 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-052480425-0524-0180425-0524-0280425-0524-03
MetaxaloneMetaxalone 640 mg/1TabletOralINA Pharmaceutics Inc74157-01874157-0018-60
MetaxaloneMetaxalone 800 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-867868788-8678-0168788-8678-09

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
ProductStrengthForm · routeLabelerProduct NDC
MetaxaloneMetaxalone 800 mg/1TabletOralActavis Pharma, Inc.0591-2341
MetaxaloneMetaxalone 800 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-093
MetaxaloneMetaxalone 800 mg/1TabletOralBryant Ranch Prepack63629-8014
MetaxaloneMetaxalone 800 mg/1TabletOralDoc Rx69306-100
MetaxaloneMetaxalone 800 mg/1TabletOralProficient Rx LP71205-326
MetaxaloneMetaxalone 800 mg/1TabletOralBryant Ranch Prepack71335-0375
MetaxaloneMetaxalone 800 mg/1TabletOralDirect_Rx72189-645
MetaxaloneMetaxalone 800 mg/1TabletOralAsclemed USA, Inc.76420-898
MetaxaloneMetaxalone 800 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0131
MetaxaloneMetaxalone 800 mg/1TabletOralSportpharm LLC85766-011

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