Sodium Chloride
0.9% Sodium Chloride Injection, USP in FLEBOFLEX and FLEBOFLEX LUER Plastic Container
Approved
Approval ID
eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
LABORATORIOS GRIFOLS SA
DUNS: 461842294
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 Code76297-001
Application NumberANDA207956
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 19, 2022
FDA Product Classification
INGREDIENTS (2)
Sodium ChlorideActive
Quantity: 9 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT