Methocarbamol (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — Carton Labeling

NDC 0517-1825-10
Methocarbamol Injection, USP
1,000 mg/10 mL (100 mg/mL)
10 x 10 mL Single-Dose Vials
Rx Only
For Intravenous or Intramuscular Use
AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Carton Labeling
(click image for full-size original)

Serialization Label

Serialization Label
(click image for full-size original)
METHOCARBAMOL methocarbamol injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-1825
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOCARBAMOL (METHOCARBAMOL) METHOCARBAMOL 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 300 0.5 mL in 1 mL
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-1825-10 10 VIAL in 1 CARTON contains a VIAL (0517-1825-01)
1 NDC:0517-1825-01 10 mL in 1 VIAL This package is contained within the CARTON (0517-1825-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207496 01/15/2018
Labeler — American Regent, Inc. (002033710)
Establishment
Name Address ID/FEI Operations
American Regent, Inc. 116981917 analysis (0517-1825)
Establishment
Name Address ID/FEI Operations
American Regent, Inc. 606821721 manufacture (0517-1825)

Revised: 06/2019 American Regent, Inc.

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