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 4 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOL TABLETSCoupler LLC52b87514-e6e0-ab57-e063-6394a90a6b232026-05-26Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.71c21226-cd96-33ed-e053-2995a90a52692026-05-22Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLJVET PHARMACEUTICALS LLCd9e4748f-11c5-4d87-b260-1be94febe8062026-05-22Warnings, Adverse reactionsExact identifier
application number: ANDA211504
rxcui: 238175
unii: 125OD7737X
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
MethocarbamolMETHOCARBAMOL TABLETSSt. Mary's Medical Park Pharmacyfaa81ad3-2bd2-d637-e053-6294a90a2d362026-05-10Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOL TABLETSProficient Rx LP23163bc1-dec7-41f6-baed-eedebfd6be7e2026-05-01Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLRedpharm Drug44f2aa92-4619-021e-e063-6394a90a296c2026-04-21Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLSportpharm LLC64a06ef2-a062-49cc-9526-03c22b6ced2c2026-04-03Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSAdvanced Rx of Tennessee, LLC4de118fe-bd8e-6cc4-e063-6394a90a13202026-03-25Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Methocarbamol Tablets, USP, 750 mgMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.60ebbdc4-7b0d-4ad4-a7ff-d99e9a1cb33c2026-03-23Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLDoc Rxf4956165-3605-4ff3-9fd1-70157edc08ca2026-03-19Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLMisemer Pharmaceuticale89ae224-ed25-4ae7-e053-2a95a90a9c0e2026-03-18Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLOxford Pharmaceuticals, LLC06dc72a6-ef3a-425a-9194-a9d228093cc42026-03-17Warnings, Adverse reactionsExact identifier
unii: 125OD7737X

Reported adverse events (FAERS/openFDA)#

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