MedPath

Methocarbamol

Methocarbamol Tablets

Approved
Approval ID

2bdfecbb-d305-4bed-94bf-5c392b07e210

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 9, 2010

Manufacturers
FDA

Keltman Pharmaceuticals Inc.

DUNS: 362861077

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 Code68387-340
Application NumberANDA085159
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methocarbamol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2010
FDA Product Classification

INGREDIENTS (6)

METHOCARBAMOLActive
Quantity: 750 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Methocarbamol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68387-342
Application NumberANDA085159
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methocarbamol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2010
FDA Product Classification

INGREDIENTS (6)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHOCARBAMOLActive
Quantity: 500 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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Methocarbamol - FDA Drug Approval Details