Home NDC 72162-1083 Metaxalone
Product NDC 72162-1083
11-digit product format 721621083
Labeler code 72162
Product ID 72162-1083_d6b5c3d1-07f5-48a7-b942-ae3895d65986
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metaxalone
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
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 72162-1083-1 Metaxalone 100 in 1 BOTTLE TABLET 100 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-1083 METAXALONE TABLET [BRYANT RANCH PREPACK] 100 Current NDC, 1 package rows 20241115_a12304b7-6477-4518-8db5-898879c62caf.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 Sample Exclude flag Status 72162-1083-1 72162108301 100 TABLET in 1 BOTTLE (72162-1083-1) 100 tablet 2024-11-13 No No Current