NDC 80425-0084-02 - 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
- 80425-0084
- Requested NDC
- 80425-0084-02
- Package NDCs from labels
- 80425-0084-3, 80425-0084-2, 80425-0084-02
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Effective date
- 2024-12-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Metaxalone - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0084-2 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | 6 | |
| 80425-0084-3 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0084 | METAXALONE TABLET [ADVANCED RX OF TENNESSEE, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250101_b3279496-293e-7e1f-e053-2a95a90ab506.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0084-2 | EA - Each | 80425-0084 | 0bd6001e-21e6-4e1b-bd92-81beae16e8bf | 1 | 2023-06-06 |
| 80425-0084-3 | EA - Each | 80425-0084 | 9c842557-3d8c-4065-8b60-eec73de87d75 | 1 | 2023-06-06 |
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 | 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 |
| Metaxalone | METAXALONE | Asclemed USA, Inc. | f4a0e910-2b20-46d4-b49e-21fb15925b58 | 2026-04-17 | Warnings, Adverse reactions | 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 | ANDA203399 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | AvKARE | 4c3ae824-48a9-fd91-e063-6394a90a9a54 | 2026-03-04 | Warnings, Adverse reactions | ANDA203399 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Sportpharm LLC | 5bcdc9d3-8827-4d05-8783-4519f1b284a3 | 2026-02-03 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | INA Pharmaceutics Inc | fc6de1a6-26aa-47ac-a5d2-bf127a6ca563 | 2026-02-03 | Warnings, Adverse reactions | 1NMA9J598Y |
| Metaxalone | METAXALONE | Direct_Rx | 45726fbc-3450-63f7-e063-6394a90a671a | 2026-01-14 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| METAXALONE | METAXALONE | DIRECT RX | 49250bbf-fbfe-07cd-e054-00144ff88e88 | 2026-01-08 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.