MedPath

Methocarbamol

Methocarbamol Tablets USP R Only

Approved
Approval ID

0defd325-d763-481e-afe8-86075e3c7e79

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 13, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code42254-035
Application NumberANDA090200
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methocarbamol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2010
FDA Product Classification

INGREDIENTS (9)

METHOCARBAMOLActive
Quantity: 750 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT

Methocarbamol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42254-038
Application NumberANDA090200
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methocarbamol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2010
FDA Product Classification

INGREDIENTS (9)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
METHOCARBAMOLActive
Quantity: 500 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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Methocarbamol - FDA Drug Approval Details