MedPath
FDA Approval

Methocarbamol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 4, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Methocarbamol(500 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Rebel Distributors Corp.

Rebel Distributors Corp.

118802834

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Methocarbamol

Product Details

NDC Product Code
21695-078
Application Number
ANDA085159
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 19, 2009
Code: 125OD7737XClass: ACTIBQuantity: 500 mg in 1 1
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4JClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Methocarbamol

Product Details

NDC Product Code
21695-079
Application Number
ANDA085123
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 19, 2009
Code: 125OD7737XClass: ACTIBQuantity: 750 mg in 1 1
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4JClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
© Copyright 2025. All Rights Reserved by MedPath