Metaxalone
- Product NDC
- 71335-0099
- Requested package NDC
- 71335-0099-3
- 11-digit product format
- 713350099
- Labeler code
- 71335
- Product ID
- 71335-0099_3104ba9e-15ed-412f-9839-ecbcdf7bb282
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207466
- Marketing category
- ANDA
- Marketing start
- 2017-08-31
- Marketing end
- 0000-00-00
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 package | package | 71335-0099 | 71335-0099-3 | D | Discontinued by firm | 2026-08-10 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207466-001 | METAXALONE | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | |
| A207466-002 | METAXALONE | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207466-001 | AB |
| A207466-002 | AB |
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 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207466-002 | METAXALONE | 400MG | TABLET / ORAL | AB | 2020-03-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207466-001 | METAXALONE | 800MG | TABLET / ORAL | AB | 2017-08-31 | 87673890dc5c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207466-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207466-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207466-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207466-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207466-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207466-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207466-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207466-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207466-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207466-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207466-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207466-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207466-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207466-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207466-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207466-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207466-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207466-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207466-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207466-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207466-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207466-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207466-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207466-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207466-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207466-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207466-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A207466-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207466-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207466-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207466-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A207466-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207466-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A207466-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207466-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207466-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207466-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207466-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A207466-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207466-001 | AB | 1 | 87673890dc5c… |
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 | Preferred Pharmaceuticals Inc. | 01199953-8124-4ace-947f-7b11989b44c3 | 2026-07-24 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | Preferred Pharmaceuticals Inc. | 8aa84e64-0075-4f22-a576-da085f32d56c | 2026-06-17 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | Highmark Pharma LLC | 834be129-cfb5-4420-b660-025833376b3e | 2026-04-29 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | Advanced Rx of Tennessee, LLC | 4facde6f-1828-9138-e063-6294a90a1ec1 | 2026-04-17 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | REMEDYREPACK INC. | fe82b33b-2a24-4477-91ca-b23e59156675 | 2026-02-02 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | Northwind Health Company, LLC | f2b46d69-1c20-5ae9-e053-2a95a90a60a9 | 2026-01-01 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | BluePoint Laboratories | c91c0fb0-0b61-4e45-8bea-d0bf57ca7068 | 2025-07-07 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | Advanced Rx of Tennessee, LLC | 36c1d263-48ce-831b-e063-6394a90a0a2b | 2025-05-29 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | Major Pharmaceuticals | 8c1e10fe-0330-4bf8-a94d-aeed80f6aef1 | 2025-03-03 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | PD-Rx Pharmaceuticals, Inc. | edc6ba8d-2d45-4833-8dc7-e2d4e5d72856 | 2025-02-04 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | Dr. Reddys Laboratories Limited | 02eb5938-cd59-4a81-853d-a4148d813a94 | 2025-01-20 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | American Health Packaging | b6afb4d3-eb3e-4e9f-9aa9-a44cfacb959c | 2024-08-29 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | ScieGen Pharmaceuticals, Inc. | 1cef46bb-e590-4a58-82e0-7cf1fc3836a5 | 2024-08-21 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | Proficient Rx LP | 9c7d0cd4-625a-485e-9d13-ce854630148c | 2024-03-01 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | Misemer Pharmaceuticals, Inc. | d0276e7b-a1c9-61f3-e053-2a95a90ae3aa | 2024-02-01 | Warnings, Adverse reactions | 207466 ANDA207466 |
| Metaxalone | METAXALONE | CIPLA USA INC. | c1f49112-e8ce-43a9-bdb8-1a3db4fb6bc4 | 2023-06-08 | Warnings, Adverse reactions | 207466 ANDA207466 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0099-3 | 71335009903 | 90 TABLET in 1 BOTTLE (71335-0099-3) | 90 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |