Sodium Acetate (Page 2 of 2)

HOW SUPPLIED

Sodium Acetate Injection, USP, is packaged in a pharmacy bulk package vial, 25 vials per tray and is available as follows:

Product

No.

NDC

No.

Sodium

Acetate

Content

(%)

Na+

mEq/mL

CH 3 COO

mEq/mL

mOsmol/

mL

Fill

Vol.

(mL)

66B1

63323-066-61

16.4

2

2

4

100

32B1

63323-032-61

32.8

4

4

8

100

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

address_band

45828E

Revised: March 2008

PACKAGE LABEL — PRINCIPAL DISPLAY — Sodium Acetate Pharmacy Bulk Package Vial Label

NDC 63323-032-61

32B1

Sodium Acetate Injection, USP

Concentrated

Pharmacy Bulk Package — Not for Direct Infusion

4 mEq/mL

For IV Use Only After Dilution

100 mL

Rx only

sodium_acetate_vlblsodium_acetate_vlbl
SODIUM ACETATE
sodium acetate injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-032
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM ACETATE (SODIUM CATION) SODIUM CATION 328 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ACETIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-032-61 25 VIAL, PHARMACY BULK PACKAGE (25 VIAL) in 1 TRAY contains a VIAL, PHARMACY BULK PACKAGE
1 100 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the TRAY (63323-032-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/01/2000
Labeler — APP Pharmaceuticals, LLC (608775388)
Establishment
Name Address ID/FEI Operations
APP Pharmaceuticals, LLC 023648251 MANUFACTURE

Revised: 07/2011 APP Pharmaceuticals, LLC

Page 2 of 2 1 2

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 © 2020. All Rights Reserved.