FDA.reportPublic FDA data

NDC 80425-0524-01 - 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
80425-0524
Requested NDC
80425-0524-01
Package NDCs from labels
80425-0524-1, 80425-0524-2, 80425-0524-3, 80425-0524-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-05-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metaxalone - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-05-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0524-1Metaxalone30 in 1 BOTTLETABLET301
80425-0524-2Metaxalone60 in 1 BOTTLETABLET601
80425-0524-3Metaxalone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0524-1EA - Each80425-052408419fba-cfad-4343-9fdb-1f646881dd4612025-07-08
80425-0524-2EA - Each80425-05248e66ee0f-8ca6-40d0-9d75-3609938df18612025-07-08
80425-0524-3EA - Each80425-052496efdfd4-a767-42c8-95b1-b34d45a5828c12025-07-08

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 7 of 10 · 184 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONEActavis Pharma, Inc.b3a4f6bc-abd4-4b8e-970f-59b3aa6f17a02025-07-30Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEBluePoint Laboratoriesc91c0fb0-0b61-4e45-8bea-d0bf57ca70682025-07-07Warnings, Adverse reactionsExact identifier
application number: ANDA207466
rxcui: 351254
unii: 1NMA9J598Y
Ferrum rosatum GraphitesFERRUM ROSATUM GRAPHITESUriel Pharmacy Inc.1a4ca338-eada-4c0f-8bce-480244940c892025-06-27WarningsExact identifier
unii: 1K09F3G675
AquavitAQUAVITUriel Pharmacy Inc.c1c0887a-c388-c737-e053-2a95a90a076c2025-06-06WarningsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONEAdvanced Rx of Tennessee, LLC36c1d263-48ce-831b-e063-6394a90a0a2b2025-05-29Warnings, Adverse reactionsExact identifier
application number: ANDA207466
ndc (package): 80425-0524-1
ndc (package): 80425-0524-2
ndc (package): 80425-0524-3
ndc (product): 80425-0524
ndc11 (package): 80425052401
rxcui: 351254
spl id: 36c1d263-48d0-831b-e063-6394a90a0a2b
spl set id: 36c1d263-48ce-831b-e063-6394a90a0a2b
unii: 1NMA9J598Y
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONEAmneal Pharmaceuticals LLC3aa9dba9-29b0-4520-a0f7-66d19d52c6bc2025-03-28Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONEMajor Pharmaceuticals8c1e10fe-0330-4bf8-a94d-aeed80f6aef12025-03-03Warnings, Adverse reactionsExact identifier
application number: ANDA207466
rxcui: 351254
unii: 1NMA9J598Y
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
CalamineFERRIC OXIDE REDPreferred Pharmaceuticals Inc.326f3d80-c1bf-4cf0-a662-58e02ed7ee672025-02-12Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONEDr. Reddys Laboratories Limited02eb5938-cd59-4a81-853d-a4148d813a942025-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA207466
ndc (product): 55111-650
rxcui: 351254
spl id: 2c27dda6-06ef-c6ae-e063-6294a90a8ff2
spl set id: 02eb5938-cd59-4a81-853d-a4148d813a94
unii: 1NMA9J598Y
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: 1K09F3G675
MetaxaloneMETAXALONEAdvanced Rx of Tennessee, LLCb3279496-293e-7e1f-e053-2a95a90ab5062024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEAdvanced Rx Pharmacy of Tennessee, LLCbd1c9022-aadc-af1f-e053-2995a90a0b422024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEAdvanced Rx Pharmacy of Tennessee, LLCb713a0f2-d47a-0ae7-e053-2995a90a5b852024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEQuality Care Products, LLCf05bb280-6736-4215-be5b-0e5f7991cd872024-12-17Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y

Reported adverse events (FAERS/openFDA)#

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