SODIUM CHLORIDE (Page 2 of 2)

HOW SUPPLIED

0.9% SODIUM CHLORIDE INJECTION, USP is supplied in the following dosage forms:

NDC 51662-1522-1 0.9% SODIUM CHLORIDE INJECTION, USP, 500mL BAG

HF Acquisition Co LLC, DBA HealthFirst
Mukilteo, WA 98275

Also supplied in the following manufacture supplied dosage forms

Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table.

* Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
† Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

ICU Medical is transitioning NDC codes from “0409” to “0990” labeler code. Both NDC codes are expected to be in the market for a period of time.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: 1/2018

EN-4686

PRINCIPAL DISPLAY PANEL — SERIALIZED LABEL NDC 51662-1522-1

PRINCIPAL DISPLAY PANEL — NDC 0990-7983-55 FRONT LABEL

PRINCIPAL DISPLAY PANEL — NDC 0990-7983-55 REAR LABEL

SODIUM CHLORIDE sodium chloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1522(NDC:0990-7983) Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 900 mg in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51662-1522-1 500 mL in 1 BAG None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA016366 08/04/2020

Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	relabel (51662-1522)

Revised: 08/2020 HF Acquisition Co LLC, DBA HealthFirst