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Methocarbamol

Methocarbamol Injection, USP RX only

Approved
Approval ID

68dd9c24-4d41-48be-9f54-fceb787bb443

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 18, 2023

Manufacturers
FDA

Somerset Therapeutics, LLC

DUNS: 079947873

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 Code70069-101
Application NumberANDA207522
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methocarbamol
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 18, 2023
FDA Product Classification

INGREDIENTS (5)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHOCARBAMOLActive
Quantity: 100 mg in 1 mL
Code: 125OD7737X
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 0.5 mL in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Methocarbamol - FDA Drug Approval Details