NDC Code(s) : 70655-071-10, 70655-071-25
Packager : Renaissance SSA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MethocarbamolMethocarbamol INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70655-071
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOCARBAMOL(UNII: 125OD7737X)
(METHOCARBAMOL - UNII:125OD7737X) 		METHOCARBAMOL100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)0.5 mL in 1 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70655-071-2525 in 1 PACKAGE 19/01/2017
1NDC:70655-071-1010 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208116 01/19/2017

PRINCIPAL DISPLAY PANEL

NDC 70655-071-25
Methocarbamol Injection, USP
1,000 mg/ 10 mL
(100 mg/ mL)
25 x 10 mL Single Dose Vials
Rx Only

PRINCIPAL DISPLAY PANEL NDC 70655-071-25 Methocarbamol Injection, USP 1,000 mg/ 10 mL (100 mg/ mL) 25 x 10 mL Single Dose Vials Rx Only