Home DailyMed bc2cec64-f842-532c-e053-2995a90a554d Metaxalone Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Central Packaging | Central Packaging, LLC
Effective date 2021-02-25
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-05-31 20:35:43 Label at a glance# Product Metaxalone
Active ingredient METAXALONE
Label structure 2 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 351254 metaxalone 800 MG Oral Tablet PSN 1 351254 metaxalone 800 MG Oral Tablet SCD 1
DailyMed Pharmacologic Classes# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80175-0472-9 Metaxalone 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80175-0472 METAXALONE TABLET [CENTRAL PACKAGING] 1 Legacy NDC, 1 package rows 20210226_bc2cec64-f842-532c-e053-2995a90a554d.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 1 matching rows.
Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 1 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208774-001 METAXALONE METAXALONE 800MG TABLET / ORAL 2018-09-24
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A208774-001 METAXALONE 800MG TABLET / ORAL 2018-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208774-001 METAXALONE 800MG TABLET / ORAL 2018-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208774-001 METAXALONE 800MG TABLET / ORAL 2018-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208774-001 METAXALONE 800MG TABLET / ORAL 2018-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208774-001 METAXALONE 800MG TABLET / ORAL 2018-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208774-001 METAXALONE 800MG TABLET / ORAL 2018-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208774-001 METAXALONE 800MG TABLET / ORAL 2018-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208774-001 METAXALONE 800MG TABLET / ORAL 2018-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208774-001 METAXALONE 800MG TABLET / ORAL 2018-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208774-001 METAXALONE 800MG TABLET / ORAL AB 2018-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208774-001 METAXALONE 800MG TABLET / ORAL AB 2018-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208774-001 METAXALONE 800MG TABLET / ORAL AB 2018-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208774-001 METAXALONE 800MG TABLET / ORAL AB 2018-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208774-001 METAXALONE 800MG TABLET / ORAL AB 2018-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208774-001 METAXALONE 800MG TABLET / ORAL AB 2018-09-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208774-001 METAXALONE 800MG TABLET / ORAL AB 2018-09-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208774-001 METAXALONE 800MG TABLET / ORAL AB 2018-09-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208774-001 METAXALONE 800MG TABLET / ORAL BX 2018-09-24 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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.
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Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
