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 7 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOL TABLETSRedpharm Drug46e983de-434e-7ff3-e063-6394a90aa4662025-12-27Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC18810520-3040-4802-e063-6294a90a1ec02025-12-03Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLAsclemed USA, Inc.7f297ac6-a580-4539-a770-fe5d15c2b9222025-11-24Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Methocarbamol Tablets, USP, 500 mgMETHOCARBAMOLMarlex Pharmaceuticals, Inc.d2e38ac9-1cf3-14ca-e053-2a95a90a85222025-11-21Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLOncora Pharma, LLC440d6c99-8aca-af07-e063-6294a90aee3d2025-11-20Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLPHOENIX RX LLC39bc9ecf-837e-5bb8-e063-6394a90a917e2025-11-13Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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