Sodium Chloride
0.9% Sodium Chloride Injection, USP in FLEBOFLEX and FLEBOFLEX LUER Plastic Container
Approved
Approval ID
4d0bfd28-460a-48ba-bd17-cf75e56d62f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
SOLA Pharmaceuticals, LLC
DUNS: 080121345
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 Code70512-841
Application NumberANDA207956
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (2)
Sodium ChlorideActive
Quantity: 9 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT