Prescription drug · ANDA
Metaxalone NDC 61919-832
Metaxalone 800 mg/1 · Tablet · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-832-71 | 6191908327161919083271 | 100 TABLET in 1 BOTTLE (61919-832-71)Marketed from Jan 6, 2020 | |
| 61919-832-72 | 6191908327261919083272 | 120 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
N461919083271followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Metaxalone products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 204770
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1083 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2097 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-232 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0771 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1435 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2066 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-3650 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-3670 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0958 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | PHOENIX RX LLC | 85509-1435 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7675 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Proficient Rx LP | 71205-426 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-289 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-792 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Sportpharm LLC | 85766-143 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Quality Care Products, LLC | 55700-494 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0122 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Doc Rx | 69306-311 |