FDA.reportPublic FDA data

NDC 80425-0122-01 - 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
80425-0122
Requested NDC
80425-0122-01
Package NDCs from labels
80425-0122-3, 80425-0122-2, 80425-0122-1, 80425-0122-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metaxalone - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0122-1Metaxalone30 in 1 BOTTLETABLET307
80425-0122-2Metaxalone60 in 1 BOTTLETABLET607
80425-0122-3Metaxalone90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0122METAXALONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_b713a0f2-d47a-0ae7-e053-2995a90a5b85.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0122-1EA - Each80425-0122fd38f6a3-d0da-4a2d-829e-ddf6685746bc12023-04-07
80425-0122-2EA - Each80425-01223cf8b25b-f836-48b3-85c5-8dbc14a522b912023-04-07
80425-0122-3EA - Each80425-012290c8319a-268f-420c-8409-a3357118e5c412023-04-07

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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetaxaloneMETAXALONENorthwind Health Company, LLCd9cefc55-7643-ce9b-e053-2a95a90aff122026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA204770
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONENorthwind Health Company, LLCf2b46d69-1c20-5ae9-e053-2a95a90a60a92026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEA-S Medication Solutionsd4caa7c6-afb5-43a2-ba38-cf30106b1d622025-12-05Warnings, Adverse reactionsExact identifier
application number: ANDA204770
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEAvPAK9b21a974-6a5a-9efb-e9de-4703632171262025-11-26Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEPHOENIX RX LLC3a7c8b4d-7add-cb31-e063-6294a90a37f82025-10-21Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEPHOENIX RX LLC413b300d-4163-afef-e063-6394a90a618f2025-10-15Warnings, Adverse reactionsExact identifier
application number: ANDA204770
rxcui: 351254
unii: 1NMA9J598Y
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
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEAdvanced Rx of Tennessee, LLC36c1d263-48ce-831b-e063-6394a90a0a2b2025-05-29Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEAmneal Pharmaceuticals LLC3aa9dba9-29b0-4520-a0f7-66d19d52c6bc2025-03-28Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEMajor Pharmaceuticals8c1e10fe-0330-4bf8-a94d-aeed80f6aef12025-03-03Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEPD-Rx Pharmaceuticals, Inc.edc6ba8d-2d45-4833-8dc7-e2d4e5d728562025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEDr. Reddys Laboratories Limited02eb5938-cd59-4a81-853d-a4148d813a942025-01-20Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
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
application number: ANDA204770
ndc (package): 80425-0122-2
ndc (package): 80425-0122-3
ndc (package): 80425-0122-1
ndc (product): 80425-0122
ndc11 (package): 80425012201
rxcui: 351254
spl id: 2a99aae5-c903-7940-e063-6294a90a4146
spl set id: b713a0f2-d47a-0ae7-e053-2995a90a5b85
unii: 1NMA9J598Y
MetaxaloneMETAXALONEQuality Care Products, LLCf05bb280-6736-4215-be5b-0e5f7991cd872024-12-17Warnings, Adverse reactionsExact identifier
application number: ANDA204770
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEBryant Ranch Prepacka12304b7-6477-4518-8db5-898879c62caf2024-11-13Warnings, Adverse reactionsExact identifier
application number: ANDA204770
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEBryant Ranch Prepackc2dd7071-cba3-410c-ade5-9d7e5af420382024-09-16Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEAmneal Pharmaceuticals of New York LLCde3448df-4ca1-44ec-bad1-486549cddf642024-08-30Warnings, Adverse reactionsExact identifier
unii: 1NMA9J598Y

Reported adverse events (FAERS/openFDA)#

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