Prescription drug · ANDA
Metaxalone NDC 85622-950
Metaxalone 400 mg/1 · Tablet · Oral · Blue Heron Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85622-950-10 | 85622095010 | 100 TABLET in 1 BOTTLE (85622-950-10)Marketed from Sep 15, 2026 |
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 — 400 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207466
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 85622-950_1266e46d-5a40-401b-9aa0-a9a6d0d3111bSPL ID 1266e46d-5a40-401b-9aa0-a9a6d0d3111b
- 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
N485622095010followed by a unit qualifier and the quantityPackage 85622-0950-10. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 207466
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 | Proficient Rx LP | 71205-016 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | BluePoint Laboratories | 68001-485 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-028 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-592 |
| Metaxalone | Metaxalone 400 mg/1 | TabletOral | Misemer Pharmaceuticals, Inc. | 0276-0508 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-171 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-323 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0524 |
| Metaxalone | Metaxalone 400 mg/1 | TabletOral | Highmark Pharma LLC | 87450-101 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4559 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | American Health Packaging | 60687-663 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0580 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8678 |
| Metaxalone | Metaxalone 400 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-474 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Dr. Reddys Laboratories Limited | 55111-650 |
| Metaxalone | Metaxalone 400 mg/1 | TabletOral | CIPLA USA INC. | 69097-998 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4168 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6831 |