Prescription drug · ANDA
Metaxalone NDC 50090-3650
Metaxalone 800 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3650-0 | 50090365000 | 30 TABLET in 1 BOTTLE (50090-3650-0)Marketed from Oct 11, 2018 | |
| 50090-3650-1 | 50090365001 | 60 TABLET in 1 BOTTLE (50090-3650-1)Marketed from Oct 11, 2018 | |
| 50090-3650-2 | 50090365002 | 15 TABLET in 1 BOTTLE, PLASTIC (50090-3650-2)Marketed from Nov 22, 2016 | |
| 50090-3650-3 | 50090365003 | 20 TABLET in 1 BOTTLE, PLASTIC (50090-3650-3)Marketed from Nov 22, 2016 | |
| 50090-3650-4 | 50090365004 | 10 TABLET in 1 BOTTLE, PLASTIC (50090-3650-4)Marketed from Nov 22, 2016 | |
| 50090-3650-5 | 50090365005 | 100 TABLET in 1 BOTTLE (50090-3650-5)Marketed from Oct 18, 2018 |
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
- A-S Medication Solutions
- 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 50090-3650_8d2d65ad-3146-4218-8373-539cf48d3fe2SPL ID 8d2d65ad-3146-4218-8373-539cf48d3fe2SPL set ID d4caa7c6-afb5-43a2-ba38-cf30106b1d62RxCUI 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
N450090365000followed by a unit qualifier and the quantityPackage 50090-3650-00. 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 discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. Metaxalone 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 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 | REMEDYREPACK INC. | 70518-0771 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2066 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-232 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0958 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1435 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Proficient Rx LP | 71205-426 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | PHOENIX RX LLC | 85509-1435 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1083 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7675 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Direct_Rx | 61919-832 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | DIRECT RX | 61919-832 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Direct_Rx | 61919-832 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | DIRECT RX | 61919-832 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-3670 |
| Metaxalone | Metaxalone 800 mg/1 | TabletOral | Sportpharm LLC | 85766-143 |
| 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 | 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 | Bryant Ranch Prepack | 63629-2097 |
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