Sodium Chloride
0.9% SODIUM CHLORIDE IRRIGATION, USP
Approved
Approval ID
3cfdeee0-ff14-4341-8396-b11c2a037c60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 29, 2020
Manufacturers
FDA
ICU Medical Inc.
DUNS: 118380146
Products 3
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 Code0990-6138
Application NumberNDA017514
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM CHLORIDE
Product Specifications
Route of AdministrationIRRIGATION
Effective DateOctober 29, 2020
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEActive
Quantity: 900 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7138
Application NumberNDA017514
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM CHLORIDE
Product Specifications
Route of AdministrationIRRIGATION
Effective DateOctober 29, 2020
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEActive
Quantity: 900 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7972
Application NumberNDA018314
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM CHLORIDE
Product Specifications
Route of AdministrationIRRIGATION
Effective DateOctober 29, 2020
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 900 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB