ROBAXIN
Approved
Approval ID
5666ece8-9a10-4dcc-a7dc-3cd29df10e28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METHOCARBAMOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-981
Application NumberNDA011011
Product Classification
M
Marketing Category
C73594
G
Generic Name
METHOCARBAMOL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 25, 2011
FDA Product Classification
INGREDIENTS (13)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
METHOCARBAMOLActive
Quantity: 750 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 8/24/2011
CONTRAINDICATIONS
robaxin® and robaxin®-750 are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 8/24/2011
Rx Only