FDA.reportPublic FDA data

NDC 85509-2341-01 - 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
85509-2341
Requested NDC
85509-2341-01
Package NDCs from labels
85509-2341-1, 85509-2341-3, 85509-2341-6, 85509-2341-9, 85509-2341-2, 85509-2341-01
Manufacturer
PHOENIX RX LLC
Effective date
2025-10-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metaxalone - PHOENIX RX LLCPHOENIX RX LLC2025-10-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-2341-1Metaxalone100 in 1 BOTTLETABLET1002
85509-2341-2Metaxalone120 in 1 BOTTLETABLET1202
85509-2341-3Metaxalone30 in 1 BOTTLETABLET302
85509-2341-6Metaxalone60 in 1 BOTTLETABLET602
85509-2341-9Metaxalone90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-2341-1EA - Each85509-23418203ce30-10c1-4650-93a0-fc4cfd0ea8e912025-09-12
85509-2341-2EA - Each85509-2341c2516acc-737f-4ec4-8224-3799d445936812025-12-16
85509-2341-3EA - Each85509-23415c0cf6ef-64d6-4632-8d85-b9801be97a5712025-09-12
85509-2341-6EA - Each85509-2341c22db59f-a6a2-497b-b1c3-234e4491c1c212025-09-12
85509-2341-9EA - Each85509-2341ff1680f7-321b-4057-ade9-bf0e65b72f7c12025-09-12

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
MetaxaloneMETAXALONEDirect_Rx45726fbc-3450-63f7-e063-6394a90a671a2026-01-14Warnings, Adverse reactionsExact identifier
application number: ANDA203695
rxcui: 351254
unii: 1NMA9J598Y
METAXALONEMETAXALONEDIRECT RX49250bbf-fbfe-07cd-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONENorthwind Health Company, LLCd9cefc55-7643-ce9b-e053-2a95a90aff122026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONENorthwind Health Company, LLCf2b46d69-1c20-5ae9-e053-2a95a90a60a92026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
MetaxaloneMETAXALONEA-S Medication Solutionsd4caa7c6-afb5-43a2-ba38-cf30106b1d622025-12-05Warnings, Adverse reactionsExact identifier
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
application number: ANDA203695
ndc (package): 85509-2341-1
ndc (package): 85509-2341-3
ndc (package): 85509-2341-6
ndc (package): 85509-2341-9
ndc (package): 85509-2341-2
ndc (product): 85509-2341
ndc11 (package): 85509234101
rxcui: 351254
spl id: 41ae7309-4967-b721-e063-6294a90abf2c
spl set id: 3a7c8b4d-7add-cb31-e063-6294a90a37f8
unii: 1NMA9J598Y
MetaxaloneMETAXALONEPHOENIX RX LLC413b300d-4163-afef-e063-6394a90a618f2025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEActavis Pharma, Inc.b3a4f6bc-abd4-4b8e-970f-59b3aa6f17a02025-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA203695
ndc (product): 0591-2341
rxcui: 351254
spl id: ca4c1e06-87e3-4f44-aeac-3da9d4b901d3
spl set id: b3a4f6bc-abd4-4b8e-970f-59b3aa6f17a0
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
application number: ANDA203695
rxcui: 351254
unii: 1NMA9J598Y
MetaxaloneMETAXALONEAdvanced Rx Pharmacy of Tennessee, LLCb713a0f2-d47a-0ae7-e053-2995a90a5b852024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 351254
unii: 1NMA9J598Y

Reported adverse events (FAERS/openFDA)#

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