NDC codes

FDA NDC Directory
Product NDC (as listed)76420-898Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0898Add 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
76420-898-017642008980176420089801100 TABLET in 1 BOTTLE (76420-898-01)Marketed from Jan 10, 2025
76420-898-12764200898127642008981212 TABLET in 1 BOTTLE (76420-898-12)Marketed from May 13, 2025
76420-898-15764200898157642008981515 TABLET in 1 BOTTLE (76420-898-15)Marketed from Jan 10, 2025
76420-898-20764200898207642008982020 TABLET in 1 BOTTLE (76420-898-20)Marketed from Jan 10, 2025
76420-898-30764200898307642008983030 TABLET in 1 BOTTLE (76420-898-30)Marketed from Jan 10, 2025
76420-898-60764200898607642008986060 TABLET in 1 BOTTLE (76420-898-60)Marketed from Jan 10, 2025
76420-898-90764200898907642008989090 TABLET in 1 BOTTLE (76420-898-90)Marketed from Jan 10, 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
Asclemed USA, Inc.NDC labeler code 76420
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 76420-898_4fa17239-3e4c-a50f-e063-6394a90a4de5SPL ID 4fa17239-3e4c-a50f-e063-6394a90a4de5SPL set ID f4a0e910-2b20-46d4-b49e-21fb15925b58RxCUI 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

N476420089801 followed by a unit qualifier and the quantity

Package 76420-0898-01. 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 76420-898

What is NDC 76420-898?
76420-898 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 7 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?
Asclemed USA, Inc., NDC labeler code 76420. 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/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0131
MetaxaloneMetaxalone 800 mg/1TabletOralPHOENIX RX LLC85509-2341
MetaxaloneMetaxalone 800 mg/1TabletOralSportpharm LLC85766-011

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