Dextrose and Sodium Chloride
Dextrose and Sodium Chloride Injection, USP
Approved
Approval ID
4555b1bf-6d97-4798-a63d-6d34291c85ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2021
Manufacturers
FDA
ICU Medical Inc.
DUNS: 118380146
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7924
Application NumberNDA017606
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (3)
DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 0.225 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7941
Application NumberNDA017585
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (3)
DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 0.9 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7925
Application NumberNDA017799
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (3)
DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 0.3 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7926
Application NumberNDA017607
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 0.45 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB