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 18 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: QTT17582CB
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLCamber Pharmaceuticals, Inc.43af0c41-9990-4902-9384-75de5ea082832021-04-06Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLProficient Rx LP39b4362e-a26e-49cb-9d06-898bc9b0e0052021-04-01Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLSagent Pharmaceuticalsbc925726-4949-4647-bce8-e1180d36abe42021-03-12Warnings, Adverse reactionsExact identifier
rxcui: 238175
unii: 125OD7737X
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLProficient Rx LP75b964b7-3e76-4460-9777-7656b5daa32e2020-12-01Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
methocarbamolMETHOCARBAMOLBaxter Healthcare Corporationa7f70b19-75ba-4e3d-b4fe-277fe7305bf02020-09-28Warnings, Adverse reactionsExact identifier
rxcui: 238175
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLProficient Rx LP0003eccd-6147-4a7c-ae83-b2a94933e07d2020-08-01Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLGland Pharma Limited44c7fe99-8999-4747-9376-f13d3f9e56882020-07-18Warnings, Adverse reactionsExact identifier
application number: ANDA211504
ndc (package): 68083-317-01
ndc (package): 68083-317-25
ndc (product): 68083-317
ndc11 (package): 68083031701
rxcui: 238175
spl id: 36c2242f-82d7-4faa-a640-0a6e269038ff
spl set id: 44c7fe99-8999-4747-9376-f13d3f9e5688
unii: 125OD7737X
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLMeitheal Pharmaceuticals Inc.b60000fc-e99b-4994-9d36-3907e0da9e062019-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA211504
rxcui: 238175
unii: 125OD7737X
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLDr.Reddys Laboratories Inc.,c88898af-5cd8-7bed-a03e-2ab4488e20402018-11-30Warnings, Adverse reactionsExact identifier
application number: ANDA211504
rxcui: 238175
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLCd825e4d6-8b00-473a-a6e6-90f5c3ad5bec2018-10-24Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSAphena Pharma Solutions - Tennessee, LLC3757cd8e-6054-4b75-bb04-d11f34c65cbe2018-09-12Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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