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

Label
(click image for full-size original)

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

Carton
(click image for full-size original)
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

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.