NDC codes

FDA NDC Directory
Product NDC (as listed)61919-832Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61919-0832Add 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
61919-832-716191908327161919083271100 TABLET in 1 BOTTLE (61919-832-71)Marketed from Jan 6, 2020
61919-832-726191908327261919083272120 TABLET in 1 BOTTLE (61919-832-72)Marketed from Jan 6, 2020

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
DIRECT RXNDC labeler code 61919
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204770
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 61919-832_518e6042-b978-beaa-e063-6394a90a6b62SPL ID 518e6042-b978-beaa-e063-6394a90a6b62SPL set ID 9b7b4fc3-3f38-db66-e053-2995a90aaadbRxCUI 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

N461919083271 followed by a unit qualifier and the quantity

Package 61919-0832-71. 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 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 61919-832

What is NDC 61919-832?
61919-832 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by DIRECT RX. 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?
DIRECT RX, NDC labeler code 61919. 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 204770

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

FDA NDC Directory listings under ANDA 204770
ProductStrengthForm · routeLabelerProduct NDC
MetaxaloneMetaxalone 800 mg/1TabletOralBryant Ranch Prepack72162-1083
MetaxaloneMetaxalone 800 mg/1TabletOralBryant Ranch Prepack63629-2097
MetaxaloneMetaxalone 800 mg/1TabletOralAsclemed USA, Inc.76420-232
MetaxaloneMetaxalone 800 mg/1TabletOralREMEDYREPACK INC.70518-0771
MetaxaloneMetaxalone 800 mg/1TabletOralLannett Company, Inc.0527-1435
MetaxaloneMetaxalone 800 mg/1TabletOralBryant Ranch Prepack71335-2066
MetaxaloneMetaxalone 800 mg/1TabletOralA-S Medication Solutions50090-3650
MetaxaloneMetaxalone 800 mg/1TabletOralA-S Medication Solutions50090-3670
MetaxaloneMetaxalone 800 mg/1TabletOralBryant Ranch Prepack71335-0958
MetaxaloneMetaxalone 800 mg/1TabletOralPHOENIX RX LLC85509-1435
MetaxaloneMetaxalone 800 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-7675
MetaxaloneMetaxalone 800 mg/1TabletOralProficient Rx LP71205-426
MetaxaloneMetaxalone 800 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-289
MetaxaloneMetaxalone 800 mg/1TabletOralNorthwind Health Company, LLC51655-792
MetaxaloneMetaxalone 800 mg/1TabletOralSportpharm LLC85766-143
MetaxaloneMetaxalone 800 mg/1TabletOralQuality Care Products, LLC55700-494
MetaxaloneMetaxalone 800 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0122
MetaxaloneMetaxalone 800 mg/1TabletOralDoc Rx69306-311

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in