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Dextrose and Sodium Chloride

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1970

Approved
Approval ID

dcbf1907-1841-4afc-ab5d-a9893a2d7256

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 22, 2019

Manufacturers
FDA

Baxter Healthcare Corporation

DUNS: 005083209

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dextrose and Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-0077
Application NumberNDA016689
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose and Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 22, 2019
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: 200 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB

Dextrose and Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-0089
Application NumberNDA016678
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose and Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 22, 2019
FDA Product Classification

INGREDIENTS (3)

DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 900 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Dextrose and Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-0073
Application NumberNDA016697
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose and Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 22, 2019
FDA Product Classification

INGREDIENTS (3)

SODIUM CHLORIDEActive
Quantity: 450 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 2.5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Dextrose and Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-0081
Application NumberNDA016687
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose and Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 22, 2019
FDA Product Classification

INGREDIENTS (3)

DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 330 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Dextrose and Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-0085
Application NumberNDA016683
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose and Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 22, 2019
FDA Product Classification

INGREDIENTS (3)

SODIUM CHLORIDEActive
Quantity: 450 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Dextrose and Sodium Chloride - FDA Drug Approval Details