NDC 70518-4559-01 - 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
70518-4559
Requested NDC
70518-4559-01
Package NDCs from labels
70518-4559-0, 70518-4559-1, 70518-4559-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metaxalone - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4559-0Metaxalone90 in 1 BOTTLE, PLASTICTABLET901

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 8 of 10 · 184 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetaxaloneMETAXALONEBryant Ranch Prepacka12304b7-6477-4518-8db5-898879c62caf2024-11-13Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONEBryant Ranch Prepackc2dd7071-cba3-410c-ade5-9d7e5af420382024-09-16Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONEAmneal Pharmaceuticals of New York LLCde3448df-4ca1-44ec-bad1-486549cddf642024-08-30Warnings, Adverse reactionsExact identifier
rxcui: 197935
unii: 1NMA9J598Y
MetaxaloneMETAXALONEAmerican Health Packagingb6afb4d3-eb3e-4e9f-9aa9-a44cfacb959c2024-08-29Warnings, Adverse reactionsExact identifier
application number: ANDA207466
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEScieGen Pharmaceuticals, Inc.1cef46bb-e590-4a58-82e0-7cf1fc3836a52024-08-21Warnings, Adverse reactionsExact identifier
application number: ANDA207466
ndc (product): 50228-323
rxcui: 197935
rxcui: 351254
spl id: 2fa7c2d7-03c0-4f7e-aa18-d586e157e177
spl set id: 1cef46bb-e590-4a58-82e0-7cf1fc3836a5
unii: 1NMA9J598Y
MetaxaloneMETAXALONEBryant Ranch Prepacka662fd07-2896-4cbb-bafc-aa5ab179a1482024-08-12Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEBryant Ranch Prepack7f758053-2367-4c5f-9bbd-ce8ce263a6152024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEBryant Ranch Prepackc86862a4-f6ff-4268-bec6-35dedbe4cd4a2024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEBryant Ranch Prepack07ccff59-e335-40be-9e40-fd2d081976172024-07-24Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONELannett Company, Inc.8294bb3c-c8eb-474c-b567-e53cf81249e92024-06-27Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
MetaxaloneMETAXALONEProficient Rx LP9c7d0cd4-625a-485e-9d13-ce854630148c2024-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA207466
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEMisemer Pharmaceuticals, Inc.d0276e7b-a1c9-61f3-e053-2a95a90ae3aa2024-02-01Warnings, Adverse reactionsExact identifier
application number: ANDA207466
rxcui: 197935
unii: 1NMA9J598Y

Reported adverse events (FAERS/openFDA)#

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