METHOCARBAMOL
Methocarbamol Tablets, USP
Approved
Approval ID
b19fe4cb-7a72-4668-8981-db7a1f4fa5a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
ACI Healthcare USA, Inc.
DUNS: 080430318
Products 2
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 Code71093-140
Application NumberANDA203550
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHOCARBAMOL
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (11)
METHOCARBAMOLActive
Quantity: 500 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHOCARBAMOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71093-141
Application NumberANDA203550
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHOCARBAMOL
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (11)
METHOCARBAMOLActive
Quantity: 750 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT