FDA.reportPublic FDA data

NDC 80425-0283-01 - Methocarbamol

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
80425-0283
Requested NDC
80425-0283-01
Package NDCs from labels
80425-0283-1, 80425-0283-2, 80425-0283-3, 80425-0283-4, 80425-0283-5, 80425-0283-01
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
Methocarbamol - 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
80425-0283-1Methocarbamol30 in 1 BOTTLETABLET303
80425-0283-2Methocarbamol60 in 1 BOTTLETABLET603
80425-0283-3Methocarbamol90 in 1 BOTTLETABLET903
80425-0283-4Methocarbamol120 in 1 BOTTLETABLET1203
80425-0283-5Methocarbamol180 in 1 BOTTLETABLET1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0283METHOCARBAMOL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 5 package rows20250102_f6567e04-12f0-fa79-e053-2995a90a9a0e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0283-1EA - Each80425-028321ad4035-e96c-4ea2-a554-99e52baa97dd12023-06-06
80425-0283-2EA - Each80425-0283da3849c3-560f-4914-82be-2a14544bd65212023-06-06
80425-0283-3EA - Each80425-028360d3fd48-4241-4935-8761-e177eff960f412023-06-06
80425-0283-4EA - Each80425-028328f053be-6da2-4ae5-967e-cbb4ac58f89112023-06-06
80425-0283-5EA - Each80425-028316bef713-1136-4b15-bf56-71d8bab14efe12023-06-06

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 9 · 171 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCc9600cc9-7e27-6e19-e053-2995a90ab0242024-12-31Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCf4e98f9f-b20b-8608-e053-2a95a90aa6b02024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCf6567e04-12f0-fa79-e053-2995a90a9a0e2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA040489
ndc (package): 80425-0283-2
ndc (package): 80425-0283-3
ndc (package): 80425-0283-1
ndc (package): 80425-0283-5
ndc (package): 80425-0283-4
ndc (product): 80425-0283
ndc11 (package): 80425028301
rxcui: 197943
spl id: 2a9ba8f4-6ceb-e827-e063-6394a90a0300
spl set id: f6567e04-12f0-fa79-e053-2995a90a9a0e
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack8c18ffef-b2c5-4af2-af66-e22c168e76802024-12-24Warnings, Adverse reactionsExact identifier
application number: ANDA040489
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLKey Therapeuticsa88a6c84-b55a-4b6b-ac01-554079f6e3042024-10-09Warnings, Adverse reactionsExact identifier
application number: ANDA040489
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLKey Therapeuticscf931001-95bd-4900-98d5-f5ef54b49d992024-10-09Warnings, Adverse reactionsExact identifier
application number: ANDA040489
ndc (product): 70868-910
rxcui: 197943
spl id: 24143189-700c-75f8-e063-6394a90ac5ce
spl set id: cf931001-95bd-4900-98d5-f5ef54b49d99
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLFresenius Kabi USA, LLCbdf17640-221c-4c80-b48c-101daaece1d62024-08-22Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f47c39b-9373-454f-9a4e-ba6dd65dd7a42024-08-20Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackadd9e47f-11ac-e10d-bfc2-b9c52aa08fa52024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals,Inc.9d6024b2-ee1a-3a79-e053-2a95a90a1bf42024-08-14Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals, Inc.3e89a426-c741-2f44-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLNCS HealthCare of KY, LLC dba Vangard Labs32ea8117-4a35-4e2c-93bc-866544b2c3be2024-08-12Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLProficient Rx LP47d8f1c7-8395-48e0-ac6f-d35dadfb7a502024-08-01Warnings, Adverse reactionsExact identifier
application number: ANDA040489
rxcui: 197943
unii: 125OD7737X
TanlorMETHOCARBAMOLForte Bio-Pharma1dd5f7fd-7b3b-8669-e063-6394a90abe952024-07-22Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals, Inc.1c368c79-ac60-bfa7-e063-6394a90a9ff72024-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA040489
rxcui: 197943
unii: 125OD7737X
methocarbamolMETHOCARBAMOLSlate Run Pharmaceuticals, LLCbc16295e-f3aa-4ed5-9fd6-ac4c750e0bba2024-06-24Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAsclemed USA, Inc.5a9b1104-4c9a-4c8c-9e24-719a7b3a89d72024-06-13Warnings, Adverse reactionsExact identifier
application number: ANDA040489
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSPharmasource Meds, LLCf43a9389-c641-ce49-e053-2a95a90a537f2024-05-28Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC1880efb2-b97e-1e4d-e063-6294a90ab3e32024-05-18Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
ROBAXINMETHOCARBAMOLHikma Pharmaceuticals USA Inc.090a3d3d-92c3-4c30-a648-436461f817022024-04-10Warnings, Adverse reactionsExact identifier
unii: 125OD7737X

Reported adverse events (FAERS/openFDA)#

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