Home NDC 80425-0122 Metaxalone
Product NDC 80425-0122
11-digit product format 804250122
Labeler code 80425
Product ID 80425-0122_2a99aae5-c903-7940-e063-6294a90a4146
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metaxalone
Dosage form TABLET
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA204770
Marketing category ANDA
Marketing start 2016-11-22
Substance METAXALONE
Active strength 800 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A204770-001 METAXALONE METAXALONE 800MG TABLET / ORAL AB 2016-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204770-001 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.
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 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204770-001 METAXALONE 800MG TABLET / ORAL AB 2016-11-22 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Metaxalone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METAXALONE 800 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1NMA9J598Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351254 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table 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 table 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
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.
Matched openFDA labels page 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80425-0122-1 80425012201 30 TABLET in 1 BOTTLE (80425-0122-1) 30 tablet 2016-11-22 No No Current 80425-0122-2 80425012202 60 TABLET in 1 BOTTLE (80425-0122-2) 60 tablet 2016-11-22 0000-00-00 No No Current 80425-0122-3 80425012203 90 TABLET in 1 BOTTLE (80425-0122-3) 90 tablet 2016-11-22 0000-00-00 No No Current