FDA.reportPublic FDA data

NDC 0641-6103-01 - 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
0641-6103
Requested NDC
0641-6103-01
Package NDCs from labels
0641-6103-01, 0641-6103-10, 0641-6103-25
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
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6103-01ROBAXIN10 mL in 1 VIALINJECTION108
0641-6103-10ROBAXIN10 in 1 CARTONINJECTION108
0641-6103-25ROBAXIN25 in 1 CARTONINJECTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6103ROBAXIN (METHOCARBAMOL) INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 3 package rows20240412_090a3d3d-92c3-4c30-a648-436461f81702.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6103-01ML - Milliliter0641-6103fea093a9-e51d-4877-9285-77155bc4380f12013-02-13
0641-6103-10ML - Milliliter0641-610386079302-612f-4f5d-8af4-0b2d1fa573d812024-03-12
0641-6103-25ML - Milliliter0641-6103e99128e7-032f-45f6-bb13-8e212a583b2612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
METHOCARBAMOLACTIVE MOIETY125OD7737XROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

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 12 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack8c18ffef-b2c5-4af2-af66-e22c168e76802024-12-24Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLKey Therapeuticsa88a6c84-b55a-4b6b-ac01-554079f6e3042024-10-09Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLKey Therapeuticscf931001-95bd-4900-98d5-f5ef54b49d992024-10-09Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLFresenius Kabi USA, LLCbdf17640-221c-4c80-b48c-101daaece1d62024-08-22Warnings, Adverse reactionsExact identifier
rxcui: 238175
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f47c39b-9373-454f-9a4e-ba6dd65dd7a42024-08-20Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackadd9e47f-11ac-e10d-bfc2-b9c52aa08fa52024-08-20Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals,Inc.9d6024b2-ee1a-3a79-e053-2a95a90a1bf42024-08-14Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals, Inc.3e89a426-c741-2f44-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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