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Sodium Chloride

0.9% Sodium Chloride

Approved
Approval ID

107af8bc-b6af-4b85-8c8a-ea757dcef1da

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 8, 2023

Manufacturers
FDA

Cardinal Health 107, LLC

DUNS: 118546603

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55154-0126
Application NumberNDA018803
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateFebruary 6, 2023
FDA Product Classification

INGREDIENTS (4)

HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 3/8/2023

HOW SUPPLIED

0.9% Sodium Chloride Injection, USP is supplied in the following:

Unit of Sale

Concentration

0.9% Sodium Chloride Injection, USP is available overbagged with 5 x 10 mL Single-dose Plastic Fliptop Vials per bag, NDC 55154-0126-5

0.9% (10 mL)

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

Instructions for Use of the Syringe Systems

Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02.

LIFESHIELD® is the trademark of ICU Medical, Inc. and is used under license.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira logo

LAB-1097-3.0

Distributed by:

Cardinal Health

Dublin, OH 43017

L28642700223

Revised: 08/2021

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Sodium Chloride - FDA Drug Approval Details