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 | PD-Rx Pharmaceuticals, Inc. | 98713a2b-6666-44ea-9966-54e78041d27a | 2026-09-02 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | REMEDYREPACK INC. | fe82b33b-2a24-4477-91ca-b23e59156675 | 2026-08-26 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Preferred Pharmaceuticals Inc. | 01199953-8124-4ace-947f-7b11989b44c3 | 2026-07-24 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | REMEDYREPACK INC. | e9e45029-b1a4-435f-b9ca-cdfa01051bc8 | 2026-06-30 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Preferred Pharmaceuticals, Inc. | 1541da6a-7681-40bc-b67e-28e02a950d72 | 2026-06-17 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Preferred Pharmaceuticals Inc. | 8aa84e64-0075-4f22-a576-da085f32d56c | 2026-06-17 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | St. Mary's Medical Park Pharmacy | 5de36266-3964-5aca-e053-2991aa0a2205 | 2026-06-09 | Warnings, Adverse reactions | ANDA203695 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Direct_Rx | 8c3bc0a2-5c93-e1d6-e053-2995a90a0b83 | 2026-05-11 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| METAXALONE | METAXALONE | DIRECT RX | 9b7b4fc3-3f38-db66-e053-2995a90aaadb | 2026-05-11 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Direct_Rx | 91432cd0-8404-8029-e053-2a95a90adc1b | 2026-05-11 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | St. Mary's Medical Park Pharmacy | a23ca660-b066-1396-e053-2a95a90a30b2 | 2026-05-05 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Highmark Pharma LLC | 834be129-cfb5-4420-b660-025833376b3e | 2026-04-29 | Warnings, Adverse reactions | 1NMA9J598Y |
| Caldesene Baby | STARCH, CORN AND ZINC OXIDE | Insight Pharmaceuticals LLC | 9f12dee2-7afa-45e9-a729-0fd42bb77715 | 2026-04-22 | Warnings | O8232NY3SJ |
| Caldesene Medicated Protecting | CORNSTARCH AND ZINC OXIDE | Insight Pharmaceuticals LLC | ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b | 2026-04-22 | Warnings | O8232NY3SJ |
| Metaxalone | METAXALONE | Asclemed USA, Inc. | f4a0e910-2b20-46d4-b49e-21fb15925b58 | 2026-04-17 | Warnings, Adverse reactions | ANDA203695 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Advanced Rx of Tennessee, LLC | 4facde6f-1828-9138-e063-6294a90a1ec1 | 2026-04-17 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | AvKARE | 4c3b2aa4-fe65-507c-e063-6394a90a7b00 | 2026-03-17 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | AvKARE | 4c3ae824-48a9-fd91-e063-6394a90a9a54 | 2026-03-04 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Sportpharm LLC | 5bcdc9d3-8827-4d05-8783-4519f1b284a3 | 2026-02-03 | Warnings, Adverse reactions | ANDA203695 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | INA Pharmaceutics Inc | fc6de1a6-26aa-47ac-a5d2-bf127a6ca563 | 2026-02-03 | Warnings, Adverse reactions | 1NMA9J598Y |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.