FDA.reportPublic FDA data

NDC 50090-3650-01 - Metaxalone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50090-3650
Requested NDC
50090-3650-01
Package NDCs from labels
50090-3650-4, 50090-3650-0, 50090-3650-1, 50090-3650-2, 50090-3650-3, 50090-3650-5, 50090-3650-01
Manufacturer
A-S Medication Solutions
Effective date
2025-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metaxalone - A-S Medication SolutionsA-S Medication Solutions2025-12-05HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-3650-02023-02-07These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-12023-02-07These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-22023-02-07These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-32023-02-07These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-42023-02-07These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-52023-02-07These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-02023-01-30These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-12023-01-30These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-22023-01-30These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-32023-01-30These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-42023-01-30These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962
50090-3650-52023-01-30These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3650-0Metaxalone30 in 1 BOTTLETABLET3019
50090-3650-1Metaxalone60 in 1 BOTTLETABLET6019
50090-3650-2Metaxalone15 in 1 BOTTLE, PLASTICTABLET1519
50090-3650-3Metaxalone20 in 1 BOTTLE, PLASTICTABLET2019
50090-3650-4Metaxalone10 in 1 BOTTLE, PLASTICTABLET1019
50090-3650-5Metaxalone100 in 1 BOTTLETABLET10019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3650METAXALONE TABLET [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 6 package rows20230918_d4caa7c6-afb5-43a2-ba38-cf30106b1d62.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3650-0EA - Each50090-3650f02afdfd-092a-45df-8047-5b430e04055612021-11-09
50090-3650-1EA - Each50090-3650e0cbdc7e-0ab4-48a6-822f-c95cf40aa5d312021-11-09
50090-3650-2EA - Each50090-3650b4783981-9c5b-4341-91e0-db28dcd4884b12021-11-09
50090-3650-3EA - Each50090-365030088f62-a96c-49a3-9bcd-2aa15c19c09112021-11-09
50090-3650-4EA - Each50090-36509904adb8-4efa-45cd-9854-c8c4bf8200ab12021-11-09
50090-3650-5EA - Each50090-36508f612f72-1ffa-41e5-b308-b1323930f8ef12021-11-09

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 3 of 39 · 778 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
unii: K679OBS311
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
MetaxaloneMETAXALONEREMEDYREPACK INC.e9e45029-b1a4-435f-b9ca-cdfa01051bc82026-06-30Warnings, Adverse reactionsExact identifier
application number: ANDA204770
rxcui: 351254
unii: 1NMA9J598Y
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
MetaxaloneMETAXALONEPreferred Pharmaceuticals, Inc.1541da6a-7681-40bc-b67e-28e02a950d722026-06-17Warnings, Adverse reactionsExact identifier
application number: ANDA204770
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEPreferred Pharmaceuticals Inc.8aa84e64-0075-4f22-a576-da085f32d56c2026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUM 0.5%CARDINAL HEALTH 110, LLC. DBA LEADER51a2d74f-5ff3-9921-e063-6294a90a345a2026-06-15WarningsExact identifier
unii: K679OBS311
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratories51cadca6-a31b-c1b5-e063-6394a90a34d32026-06-15WarningsExact identifier
unii: K679OBS311
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.