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 11 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLAdvanced Rx of Tennessee, LLC2cf76cdc-820d-1c5b-e063-6294a90a35aa2025-01-30Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSAsclemed USA, Inc.edbcf8c6-0df8-4e72-885b-16d378f06c7b2025-01-28Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLRedpharm Drug, Inc.09d22ef9-a472-4db9-e063-6394a90a88702025-01-23Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
METHOCARBAMOLMETHOCARBAMOLDirectRxceb428e0-d6e4-57b7-e053-2995a90afcda2025-01-20Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
MethocarbamolMETHOCARBAMOLAdvanced Rx of Tennessee, LLCafc9d84d-c8dd-05c0-e053-2a95a90a22a22024-12-31Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAdvanced Rx of Tennessee, LLCaf73ae4b-bcf5-2e21-e053-2a95a90a2dce2024-12-31Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCc06c4a63-491c-baa2-e053-2a95a90a09ff2024-12-31Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
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
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCf6567e04-12f0-fa79-e053-2995a90a9a0e2024-12-31Warnings, Adverse reactionsExact identifier
unii: 125OD7737X

Reported adverse events (FAERS/openFDA)#

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