NDC 80425-0122-01 - 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
- 80425-0122
- Requested NDC
- 80425-0122-01
- Package NDCs from labels
- 80425-0122-3, 80425-0122-2, 80425-0122-1, 80425-0122-01
- Manufacturer
- Advanced Rx Pharmacy 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 Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0122-1 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | 7 | |
| 80425-0122-2 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | 7 | |
| 80425-0122-3 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0122 | METAXALONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20250101_b713a0f2-d47a-0ae7-e053-2995a90a5b85.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0122-1 | EA - Each | 80425-0122 | fd38f6a3-d0da-4a2d-829e-ddf6685746bc | 1 | 2023-04-07 |
| 80425-0122-2 | EA - Each | 80425-0122 | 3cf8b25b-f836-48b3-85c5-8dbc14a522b9 | 1 | 2023-04-07 |
| 80425-0122-3 | EA - Each | 80425-0122 | 90c8319a-268f-420c-8409-a3357118e5c4 | 1 | 2023-04-07 |
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 | 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 | ANDA204770 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Bryant Ranch Prepack | 7f758053-2367-4c5f-9bbd-ce8ce263a615 | 2024-08-08 | Warnings, Adverse reactions | ANDA204770 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Bryant Ranch Prepack | c86862a4-f6ff-4268-bec6-35dedbe4cd4a | 2024-08-08 | Warnings, Adverse reactions | ANDA204770 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Bryant Ranch Prepack | 07ccff59-e335-40be-9e40-fd2d08197617 | 2024-07-24 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Lannett Company, Inc. | 8294bb3c-c8eb-474c-b567-e53cf81249e9 | 2024-06-27 | Warnings, Adverse reactions | ANDA204770 0527-1435 351254 2fd9917f-213e-4c83-9319-5551cabd5c91 8294bb3c-c8eb-474c-b567-e53cf81249e9 1NMA9J598Y |
| 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 | 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | A-S Medication Solutions | ef47682d-ea41-465e-aa21-cc773d45a6f0 | 2023-10-01 | Warnings, Adverse reactions | ANDA204770 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 | ANDA204770 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Proficient Rx LP | ee86f52c-fbf4-4882-bb7d-50220736fbb3 | 2022-04-01 | Warnings, Adverse reactions | ANDA204770 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Doc Rx | 4a558a2f-f9be-40d1-8d02-dd0c8c501ef6 | 2022-03-24 | Warnings, Adverse reactions | ANDA204770 351254 1NMA9J598Y |
| Metaxalone | METAXALONE | Doc Rx | 87518046-c959-d5f3-e053-2a95a90a5f7e | 2021-09-28 | Warnings, Adverse reactions | 351254 1NMA9J598Y |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.