Procainamide Hydrochloride (Page 4 of 4)

Rx Only

INTERNATIONAL MEDICATION SYSTEMS, LIMITED
SO. EL MONTE, CA 91733, U.S.A. REV. 10-16
An Amphastar Pharmaceuticals Company

© INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2016

PRINCIPLE DISPLAY PANEL: Syringe Label

WARNING: CONTAINS BISULFITES

Rx Only

FOR THE PREPARATION OF I.V. INFUSIONS ONLY

SINGLE DOSE / DO NOT USE IF SOLUTION IS DARKER THAN LIGHT AMBER OR DISCOLORED

SEE INSERT

I MS, LIMITED

So. El Monte, CA 91733, U.S.A.

7633990D 10-16

10 mL 1000 mg 100 mg / mL

PROCAINAMIDE HYDROCHLORIDE INJECTION, USP

Approx. mg / mL

0 1 2 3 4 5 6 7 8 9

0 100 200 300 400 500 600 700 800 900

PRINCIPLE DISPLAY PANEL: Carton

open

Luer-Lock Prefilled Syringe

Rx Only

NDC 76329-3399-5

STOCK NO. 3399

PROCAINAMIDE HYDROCHLORIDE INJECTION, USP

(100 mg/mL)

1000 mg per 10 mL

FOR THE PREPARATION OF I.V. INFUSIONS ONLY

LUER-JET™ LUER-LOCK PREFILLED SYRINGE

PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76329-3399 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROCAINAMIDE HYDROCHLORIDE (PROCAINAMIDE) PROCAINAMIDE HYDROCHLORIDE 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL 0.9 mg in 1 mL SODIUM BISULFITE 0.09 mg in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76329-3399-5 5 SYRINGE in 1 PACKAGE contains a SYRINGE 1 10 mL in 1 SYRINGE This package is contained within the PACKAGE (76329-3399-5)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088636 12/21/2016

Labeler — International Medication Systems, Limited (055750020)

Establishment
Name	Address	ID/FEI	Operations
International Medication Systems, Limited		055750020	analysis (76329-3399), manufacture (76329-3399), label (76329-3399)

Revised: 12/2016 International Medication Systems, Limited