Metaxalone
- Product NDC
- 52959-596
- 11-digit product format
- 529590596
- Labeler code
- 52959
- Product ID
- 52959-596_96bd5ba7-4885-4069-976d-eb4949445264
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- NDA013217
- Marketing category
- NDA
- Marketing start
- 2007-11-01
- Marketing end
- 0000-00-00
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 52959-596 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 52959-596 | 52959-596-15 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-596 | 52959-596-20 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-596 | 52959-596-30 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-596 | 52959-596-60 | I | Inactivated by FDA | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-596-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-596-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-596-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-596-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-596-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-596-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-596-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-596-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-596-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-596-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-596-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-596-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-596-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-596-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-596-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-596-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-596-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-596-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-596-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-596-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-596-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-596-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-596-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-596-15 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52959-596-30 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52959-596-20 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52959-596-60 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52959-596-15 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52959-596-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52959-596-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52959-596-60 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52959-596-15 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52959-596-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52959-596-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52959-596-60 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52959-596-15 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52959-596-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52959-596-20 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52959-596-60 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52959-596-15 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52959-596-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52959-596-20 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52959-596-60 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52959-596-15 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52959-596-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52959-596-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52959-596-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52959-596-15 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N013217-001 | SKELAXIN | METAXALONE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N013217-003 | SKELAXIN | METAXALONE | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N013217-003 | 7122566 | 2026-02-06 | U-915 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N013217-003 | SKELAXIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2002-08-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | RLD | 2002-08-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | RLD | 2002-08-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | RLD | 2002-08-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | RLD | 2002-08-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | AB | RLD, RS | 2002-08-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N013217-001 | SKELAXIN | 400MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | AB | RLD, RS | 2002-08-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N013217-001 | SKELAXIN | 400MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | AB | RLD, RS | 2002-08-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | AB | RLD, RS | 2002-08-30 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | AB | RLD, RS | 2002-08-30 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N013217-001 | SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N013217-003 | SKELAXIN | 800MG | TABLET / ORAL | AB | RLD, RS | 2002-08-30 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N013217-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N013217-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N013217-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N013217-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N013217-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N013217-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N013217-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N013217-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N013217-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N013217-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N013217-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N013217-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N013217-003 | AB | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N013217-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N013217-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N013217-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N013217-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N013217-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N013217-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N013217-003 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N013217-003 | AB | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N013217-003 | 7122566 | 2026-02-06 | U-915 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N013217-003 | 7122566 | 2026-02-06 | U-915 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N013217-003 | 7122566 | 2026-02-06 | U-915 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N013217-003 | 7122566 | 2026-02-06 | U-915 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N013217-003 | 7714006 | 2021-12-03 | U-1050 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N013217-003 | 7122566 | 2026-02-06 | U-915 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N013217-003 | 7714006 | 2021-12-03 | U-1050 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N013217-003 | 7714006 | 2021-12-03 | U-1050 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N013217-003 | 7714006 | 2021-12-03 | U-1050 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N013217-003 | 7714006 | 2021-12-03 | U-1050 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N013217-003 | 7714006 | 2021-12-03 | U-1050 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N013217-003 | 7122566 | 2026-02-06 | U-915 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N013217-003 | 7714006 | 2021-12-03 | U-1050 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N013217-003 | 7714006 | 2021-12-03 | U-1050 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N013217-003 | 7122566 | 2026-02-06 | U-915 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N013217-003 | 7714006 | 2021-12-03 | U-1050 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N013217-003 | 7122566 | 2026-02-06 | U-915 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N013217-003 | 7122566 | 2026-02-06 | U-915 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N013217-003 | 7122566 | 2026-02-06 | U-915 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N013217-003 | 7122566 | 2026-02-06 | U-915 | a72a2bbeb626… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe1c2a6-5488-f909-3872-734054eb745a | Product name | 5 | 20181231 |
| 776ba7f6-e5b0-442b-bd42-1fdfdfd821a4 | Product name | 1 | 20150615 |
| 68c52498-c9cb-48ab-a792-a4876149361e | Product name | 1 | 20150409 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Related label |
|---|---|
| 52959-596-15 | METAXALONE TABLETS 800 mg |
| 52959-596-20 | METAXALONE TABLETS 800 mg |
| 52959-596-30 | METAXALONE TABLETS 800 mg |
| 52959-596-60 | METAXALONE TABLETS 800 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-596-15 | Metaxalone | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 52959-596-20 | Metaxalone | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 52959-596-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 52959-596-60 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52959-596-15 | EA - Each | 52959-596 | afb82983-ba52-4f32-b7f2-cfdfe6c75710 | 1 | 2012-07-24 |
| 52959-596-20 | EA - Each | 52959-596 | 5ebda117-ab73-4de6-81e6-c2c83fcb2912 | 1 | 2012-07-24 |
| 52959-596-30 | EA - Each | 52959-596 | 2313a481-db7a-4640-ab22-48e0adbd4aa6 | 1 | 2012-07-24 |
| 52959-596-60 | EA - Each | 52959-596 | 46773d4a-dca1-4da3-8b1e-6d32980ba354 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METAXALONE | ACTIVE INGREDIENT | 1NMA9J598Y | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| METAXALONE | ACTIVE MOIETY | 1NMA9J598Y | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| ALGINIC ACID | INACTIVE INGREDIENT | 8C3Z4148WZ | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| CALCIUM | INACTIVE INGREDIENT | SY7Q814VUP | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351254 | metaxalone 800 MG Oral Tablet | PSN | 1c410d74-2c12-4a6b-854e-8a03b5bf2fbf | 1 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | 1c410d74-2c12-4a6b-854e-8a03b5bf2fbf | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 52959-596-15 | 52959059615 | 15 in 1 BOTTLE | Historical |
| 52959-596-20 | 52959059620 | 20 in 1 BOTTLE | Historical |
| 52959-596-30 | 52959059630 | 30 in 1 BOTTLE | Historical |
| 52959-596-60 | 52959059660 | 60 in 1 BOTTLE | Historical |