Prescription drug · ANDA
Metaxalone NDC 50268-530
Metaxalone 800 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-530-15 | 50268053015 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-530-15) / 1 TABLET in 1 BLISTER PACK (50268-530-11)Marketed from Mar 13, 2015 |
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
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203399
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 50268-530_4481b1d7-8b54-035a-e063-6394a90ab23dSPL ID 4481b1d7-8b54-035a-e063-6394a90ab23dSPL set ID 9b21a974-6a5a-9efb-e9de-470363217126RxCUI 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
N450268053015followed by a unit qualifier and the quantityPackage 50268-0530-15. 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 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.
Other NDCs under ANDA 203399
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 | Amneal Pharmaceuticals LLC | 65162-553 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | AvKARE | 42291-985 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | AvKARE | 42291-985 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Proficient Rx LP | 63187-490 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0084 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-553 |