Prescription drug · ANDA
Metaxalone NDC 80425-0131
Metaxalone 800 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0131-2 | 8042501310280425013102 | 60 TABLET in 1 BOTTLE (80425-0131-2)Marketed from Jun 19, 2017 | |
| 80425-0131-3 | 8042501310380425013103 | 90 TABLET in 1 BOTTLE (80425-0131-3)Marketed from Jun 19, 2017 |
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
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0131_2a998081-6431-8228-e063-6294a90adc3dSPL ID 2a998081-6431-8228-e063-6294a90adc3dSPL set ID bd1c9022-aadc-af1f-e053-2995a90a0b42RxCUI 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
N480425013102followed by a unit qualifier and the quantityPackage 80425-0131-02. 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)
Indications and Usage Section INDICATIONS AND USAGE Metaxalone tablets are 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 80425-0131
- What is NDC 80425-0131?
- 80425-0131 is the product NDC for Metaxalone, Metaxalone 800 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. 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?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 203695
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 | Actavis Pharma, Inc. | 0591-2341 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-093 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8014 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Doc Rx | 69306-100 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Proficient Rx LP | 71205-326 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0375 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Direct_Rx | 72189-645 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-898 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | PHOENIX RX LLC | 85509-2341 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Sportpharm LLC | 85766-011 |