FDA.reportPublic FDA data

NDC 68083-317-01 - 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
68083-317
Requested NDC
68083-317-01
Package NDCs from labels
68083-317-01, 68083-317-25
Manufacturer
Gland Pharma Limited
Effective date
2020-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methocarbamol - Gland Pharma LimitedGland Pharma Limited2020-07-18Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-317-01Methocarbamol10 mL in 1 VIALINJECTION107
68083-317-25Methocarbamol25 in 1 CARTONINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-317METHOCARBAMOL INJECTION [GLAND PHARMA LIMITED]7Current NDC, Legacy NDC, 2 package rows20200723_44c7fe99-8999-4747-9376-f13d3f9e5688.zip

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 8 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9aed8304-fa4e-49d6-bd81-fcb3e4cc61732025-10-16Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSPHOENIX RX LLC414b2fe0-fa2b-2b18-e063-6394a90ab2b92025-10-16Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsff55df39-e314-4120-8fab-3757cbe5a8722025-10-16Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLA-S Medication Solutions069045f1-d699-41d0-b674-cdb71cd5fbd02025-10-15Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackf7ab7f11-9b5a-4d3a-a8fc-eee55b1fc0062025-10-13Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackfdea0332-1ad8-40ef-8cb9-b3c46588155d2025-10-13Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLSagent Pharmaceuticals01e7e2c7-49eb-4afb-a496-f2bd901622e92025-09-29Warnings, Adverse reactionsExact identifier
application number: ANDA211504
rxcui: 238175
unii: 125OD7737X
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLSolco Healthcare LLC32863f21-30ff-4a8b-a2e6-8ab14a37af0d2025-09-25Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Methocarbamol Tablets, USP, 500 mgMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.6ca768bf-5095-4148-82d2-a0c2dec16d872025-09-16Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Methocarbamol Tablets, USP, 500 mgMETHOCARBAMOLBryant Ranch Prepackdfb0e2ee-fd87-4100-9d44-f7a091e73a6c2025-09-12Warnings, Adverse reactionsExact identifier
unii: 125OD7737X

Reported adverse events (FAERS/openFDA)#

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