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Sodium Chloride

0.9% Sodium Chloride Injection, USP

Approved
Approval ID

99f10a41-50d9-4f06-a107-b07b71ff364a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 19, 2014

Manufacturers
FDA

US MedSource, LLC

DUNS: 032793851

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 Code61699-4888
Application NumberNDA018803
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateJune 23, 2014
FDA Product Classification

INGREDIENTS (4)

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

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Sodium Chloride - FDA Drug Approval Details