Sodium Chloride
0.9% Sodium Chloride Injection, USP Flexible Plastic Container
Approved
Approval ID
af5cdf1a-19f4-11e2-892e-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
Fresenius Medical Care North America
DUNS: 958291411
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 Code49230-300
Application NumberANDA078177
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2023
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 900 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB