FDA.reportPublic FDA data

NDC 0641-6217-01 - ROBAXIN

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
0641-6217
Requested NDC
0641-6217-01
Package NDCs from labels
0641-6217-01, 0641-6217-10, 0641-6217-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ROBAXIN Injectable (methocarbamol injection, USP)Hikma Pharmaceuticals USA Inc.2024-04-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6217-01ROBAXIN10 mL in 1 VIALINJECTION107
0641-6217-10ROBAXIN10 in 1 CARTONINJECTION107
0641-6217-25ROBAXIN25 in 1 CARTONINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6217ROBAXIN (METHOCARBAMOL) INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 3 package rows20240412_a418c43a-afe8-4a19-a57a-95c8dbe3d3d8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6217-01ML - Milliliter0641-62172438936d-92e9-4049-b7e6-e5cd29d24ec412018-04-19
0641-6217-10ML - Milliliter0641-62176b59dbca-486a-44fe-873d-0de61865480a12024-05-16
0641-6217-25ML - Milliliter0641-621762677966-065d-4f14-b2de-140ea2a4e67e12018-04-19

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 13 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLNCS HealthCare of KY, LLC dba Vangard Labs32ea8117-4a35-4e2c-93bc-866544b2c3be2024-08-12Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLProficient Rx LP47d8f1c7-8395-48e0-ac6f-d35dadfb7a502024-08-01Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
TanlorMETHOCARBAMOLForte Bio-Pharma1dd5f7fd-7b3b-8669-e063-6394a90abe952024-07-22Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals, Inc.1c368c79-ac60-bfa7-e063-6394a90a9ff72024-07-01Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
methocarbamolMETHOCARBAMOLSlate Run Pharmaceuticals, LLCbc16295e-f3aa-4ed5-9fd6-ac4c750e0bba2024-06-24Warnings, Adverse reactionsExact identifier
rxcui: 238175
unii: 125OD7737X
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLAsclemed USA, Inc.5a9b1104-4c9a-4c8c-9e24-719a7b3a89d72024-06-13Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOL TABLETSPharmasource Meds, LLCf43a9389-c641-ce49-e053-2a95a90a537f2024-05-28Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC1880efb2-b97e-1e4d-e063-6294a90ab3e32024-05-18Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Fatigue Stat CMECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODEEnergique, Incaebdb08b-48aa-46f2-930f-f98f5b06a6042024-05-08WarningsExact identifier
unii: QTT17582CB
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: QTT17582CB
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
unii: QTT17582CB
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ROBAXINMETHOCARBAMOLHikma Pharmaceuticals USA Inc.090a3d3d-92c3-4c30-a648-436461f817022024-04-10Warnings, Adverse reactionsExact identifier
application number: NDA011790
rxcui: 238175
rxcui: 207014
unii: 125OD7737X
ROBAXINMETHOCARBAMOLHikma Pharmaceuticals USA Inc.a418c43a-afe8-4a19-a57a-95c8dbe3d3d82024-04-10Warnings, Adverse reactionsExact identifier
application number: NDA011790
ndc (package): 0641-6217-01
ndc (package): 0641-6217-10
ndc (package): 0641-6217-25
ndc (product): 0641-6217
ndc11 (package): 00641621701
rxcui: 238175
rxcui: 207014
spl id: 2d52b3d7-dd93-47a3-95cf-7d4d50de5b18
spl set id: a418c43a-afe8-4a19-a57a-95c8dbe3d3d8
unii: 125OD7737X
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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