METHOCARBAMOL- methocarbamol injection injection

Methocarbamol by

Drug Labeling and Warnings

Methocarbamol by is a Prescription medication manufactured, distributed, or labeled by Renaissance Lakewood LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY

The mechanism of action of methocarbamol in humans has not been established, but may be due to general CNS depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Methocarbamol Injection USP

INGREDIENTS AND APPEARANCE

METHOCARBAMOL 
methocarbamol injection injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49396-0711
Route of Administration	PARENTERAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)	METHOCARBAMOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49396-0711-1	25 in 1 CARTON	03/10/2017
1		10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208116	03/10/2017

Labeler - Renaissance Lakewood LLC (077744035)

Registrant - Renaissance Lakewood LLC (077744035)

Establishment
Name	Address	ID/FEI	Business Operations
Renaissance Lakewood LLC		077744035	manufacture(49396-0711) , analysis(49396-0711)