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 3 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.4ef1c2c0-31e1-4f85-b645-ff47a057a9942026-06-23Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals, Inc425abc3b-2111-4fac-bf27-b685d1e657af2026-06-23Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOL TABLETSPreferred Pharmaceuticals Inc.e03878d3-d780-4e7f-b828-20ac2a1099332026-06-23Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLDirect_rx4c5c8933-a4b5-f9c2-e063-6294a90a6f002026-06-16Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack5af36a83-2b36-4fe2-8c6a-61b5516214212026-06-16Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackcc004f5c-d5fc-48c5-9f37-c59b9c37e1132026-06-16Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack9076b4ad-17be-4933-a975-7bf80cc92b492026-06-10Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f8aed5d-ba8d-4c32-872b-08ab15240cc12026-06-10Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
MethocarbamolMETHOCARBAMOLCardinal Health 107, LLC50603730-9f69-4ed7-bccf-31c474f83e142026-06-05Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLSt. Mary's Medical Park Pharmacyfd8cac57-9664-1fa0-e053-6294a90af8722026-06-02Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6466438c-4609-4554-8919-35710a1b556d2026-06-01Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3212f121-9428-4186-8f00-accf08bca4732026-05-29Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack33f89a57-f65d-4e99-a3a3-690ef805d8692026-05-27Warnings, Adverse reactionsExact identifier
unii: 125OD7737X
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6af87b4e-6507-4190-b043-a6d3b440314a2026-05-27Warnings, Adverse reactionsExact identifier
unii: 125OD7737X

Reported adverse events (FAERS/openFDA)#

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