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 4 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.440bf1ba-a704-4c35-bece-0a0987fc0c112026-02-16Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.12c8da39-3a0e-4303-9655-29dd835078372026-02-16Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLPHOENIX RX LLC4abc29e9-a0cc-06cf-e063-6294a90ad8742026-02-13Warnings, Adverse reactionsExact identifier
application number: ANDA040489
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLMajor Pharmaceuticals2df34fa7-9cdc-4be4-ac6f-5771224626062026-02-10Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBostal LLCd8f10211-f96e-4cf3-9b49-986eb51b703d2026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.72f36d28-15d2-30f6-e053-2a91aa0ad1ce2026-01-30Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLUNICHEM PHARMACEUTICALS (USA), INC.5777cbb0-b5fd-4b36-ac1d-bc105fe968882026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSNorthwind Health Company, LLCf2b4ed95-0469-393a-e053-2a95a90a98ed2026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals,Inc.36c2c31c-8648-7723-e063-6294a90aec982026-01-14Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
METHOCARBAMOLMETHOCARBAMOLDIRECT RX31508051-c9cb-149b-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAvPAKbe37bc85-6a41-00d8-e053-2a95a90ae5042026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSNorthwind Health Company, LLCf2b4ed5f-3489-9ee4-e053-2995a90a25f02026-01-01Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCf31ccb09-7a9a-60af-e053-2995a90a6e972026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCdf63611f-90e4-6bbe-e053-2a95a90a2aad2026-01-01Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLProficient Rx LPe4ebe9cf-a274-47c7-b740-4b3d6e9dc52b2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA040489
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSRedpharm Drug46e983de-434e-7ff3-e063-6394a90aa4662025-12-27Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC18810520-3040-4802-e063-6294a90a1ec02025-12-03Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAsclemed USA, Inc.7f297ac6-a580-4539-a770-fe5d15c2b9222025-11-24Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
Methocarbamol Tablets, USP, 500 mgMETHOCARBAMOLMarlex Pharmaceuticals, Inc.d2e38ac9-1cf3-14ca-e053-2a95a90a85222025-11-21Warnings, Adverse reactionsExact identifier
rxcui: 197943
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLOncora Pharma, LLC440d6c99-8aca-af07-e063-6294a90aee3d2025-11-20Warnings, Adverse reactionsExact identifier
unii: 125OD7737X

Reported adverse events (FAERS/openFDA)#

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