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FDA Approval

Methocarbamol

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

FDA Approval Summary

Company
Effective Date
December 20, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Methocarbamol(750 mg in 1 1)

Manufacturing Establishments1

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

Watson Laboratories, Inc.

H.J. Harkins Company, Inc.

840054118

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
52959-099
Application Number
ANDA084276
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 20, 2011
Code: 125OD7737XClass: ACTIBQuantity: 750 mg in 1 1
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT

Methocarbamol

Product Details

NDC Product Code
52959-167
Application Number
ANDA084277
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 20, 2011
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Code: 125OD7737XClass: ACTIBQuantity: 500 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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