METHOCARBAMOL
Approved
Approval ID
bc1bbd85-3f82-5d67-e053-2995a90a5781
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 26, 2021
Manufacturers
FDA
Central Packaging
DUNS: 117617671
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 Code80175-0534
Application NumberANDA090200
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHOCARBAMOL
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2021
FDA Product Classification
INGREDIENTS (1)
METHOCARBAMOLActive
Quantity: 750 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 2/24/2021
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 2/24/2021
Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.