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 | Quality Care Products, LLC | f05bb280-6736-4215-be5b-0e5f7991cd87 | 2024-12-17 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Bryant Ranch Prepack | a12304b7-6477-4518-8db5-898879c62caf | 2024-11-13 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Bryant Ranch Prepack | c2dd7071-cba3-410c-ade5-9d7e5af42038 | 2024-09-16 | Warnings, Adverse reactions | ANDA203695 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Amneal Pharmaceuticals of New York LLC | de3448df-4ca1-44ec-bad1-486549cddf64 | 2024-08-30 | Warnings, Adverse reactions | 1NMA9J598Y |
| Metaxalone | METAXALONE | American Health Packaging | b6afb4d3-eb3e-4e9f-9aa9-a44cfacb959c | 2024-08-29 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | ScieGen Pharmaceuticals, Inc. | 1cef46bb-e590-4a58-82e0-7cf1fc3836a5 | 2024-08-21 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Bryant Ranch Prepack | a662fd07-2896-4cbb-bafc-aa5ab179a148 | 2024-08-12 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Bryant Ranch Prepack | 7f758053-2367-4c5f-9bbd-ce8ce263a615 | 2024-08-08 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Bryant Ranch Prepack | c86862a4-f6ff-4268-bec6-35dedbe4cd4a | 2024-08-08 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Bryant Ranch Prepack | 07ccff59-e335-40be-9e40-fd2d08197617 | 2024-07-24 | Warnings, Adverse reactions | ANDA203695 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Lannett Company, Inc. | 8294bb3c-c8eb-474c-b567-e53cf81249e9 | 2024-06-27 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Pure Cornstarch Baby | CORN STARCH | Walgreen Company | d0e9bd13-b568-4f7e-b036-8d23e71ad8bf | 2024-03-25 | Warnings | O8232NY3SJ |
| Metaxalone | METAXALONE | Proficient Rx LP | 9c7d0cd4-625a-485e-9d13-ce854630148c | 2024-03-01 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Misemer Pharmaceuticals, Inc. | d0276e7b-a1c9-61f3-e053-2a95a90ae3aa | 2024-02-01 | Warnings, Adverse reactions | 1NMA9J598Y |
| Metaxalone | METAXALONE | Proficient Rx LP | c796d4a1-fad4-4a0c-a459-8ae3b5b52fb6 | 2024-01-01 | Warnings, Adverse reactions | ANDA203695 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | A-S Medication Solutions | ef47682d-ea41-465e-aa21-cc773d45a6f0 | 2023-10-01 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | CIPLA USA INC. | c1f49112-e8ce-43a9-bdb8-1a3db4fb6bc4 | 2023-06-08 | Warnings, Adverse reactions | 1NMA9J598Y |
| Metaxalone | METAXALONE | Amneal Pharmaceuticals of New York LLC | f06f2b96-3684-483c-89f7-6c9201fd4664 | 2023-01-11 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Proficient Rx LP | fba1601d-3ac4-41cf-9548-35ec4994a95e | 2022-10-01 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Asclemed USA, Inc. | 02c42f72-5d78-436d-8105-8c0f8d4c0d91 | 2022-07-25 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.