NDC 85509-2341-01 - Metaxalone
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 85509-2341
- Requested NDC
- 85509-2341-01
- Package NDCs from labels
- 85509-2341-1, 85509-2341-3, 85509-2341-6, 85509-2341-9, 85509-2341-2, 85509-2341-01
- Manufacturer
- PHOENIX RX LLC
- Effective date
- 2025-10-21
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Metaxalone - PHOENIX RX LLC | PHOENIX RX LLC | 2025-10-21 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85509-2341-1 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 85509-2341-2 | Metaxalone | 120 in 1 BOTTLE | TABLET | 120 | 2 | |
| 85509-2341-3 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 85509-2341-6 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 85509-2341-9 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 85509-2341-1 | EA - Each | 85509-2341 | 8203ce30-10c1-4650-93a0-fc4cfd0ea8e9 | 1 | 2025-09-12 |
| 85509-2341-2 | EA - Each | 85509-2341 | c2516acc-737f-4ec4-8224-3799d4459368 | 1 | 2025-12-16 |
| 85509-2341-3 | EA - Each | 85509-2341 | 5c0cf6ef-64d6-4632-8d85-b9801be97a57 | 1 | 2025-09-12 |
| 85509-2341-6 | EA - Each | 85509-2341 | c22db59f-a6a2-497b-b1c3-234e4491c1c2 | 1 | 2025-09-12 |
| 85509-2341-9 | EA - Each | 85509-2341 | ff1680f7-321b-4057-ade9-bf0e65b72f7c | 1 | 2025-09-12 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metaxalone | METAXALONE | Proficient Rx LP | ee86f52c-fbf4-4882-bb7d-50220736fbb3 | 2022-04-01 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Doc Rx | 4a558a2f-f9be-40d1-8d02-dd0c8c501ef6 | 2022-03-24 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Doc Rx | 87518046-c959-d5f3-e053-2a95a90a5f7e | 2021-09-28 | Warnings, Adverse reactions | ANDA203695 351254 1NMA9J598Y |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.