Prescription drug · ANDA
Metaxalone NDC 50228-474
Metaxalone 400 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-474-10 | 50228047410 | 1000 TABLET in 1 BOTTLE (50228-474-10)Marketed from Apr 30, 2020 | |
| 50228-474-30 | 50228047430 | 30 TABLET in 1 BOTTLE (50228-474-30)Marketed from Apr 30, 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 — 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 50228-474_2fa7c2d7-03c0-4f7e-aa18-d586e157e177SPL ID 2fa7c2d7-03c0-4f7e-aa18-d586e157e177SPL set ID 1cef46bb-e590-4a58-82e0-7cf1fc3836a5RxCUI 197935, 351254UNII 1NMA9J598YUPC 0350228323055, 0350228323017, 0350228323307, 0350228474108, 0350228474306
- 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
N450228047410followed by a unit qualifier and the quantityPackage 50228-0474-10. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. Metaxalone tablet is a muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
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 400 mg/1 | TabletOral | Blue Heron Pharmaceuticals, LLC | 85622-950 |
| 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 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 |