Dextrose
5% Dextrose Injection, USP
Approved
Approval ID
bd250a46-d229-4e80-b5a1-b34169ccecc4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextrose Monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-236
Application NumberANDA207449
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextrose Monohydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 24, 2022
FDA Product Classification
INGREDIENTS (1)
DEXTROSE MONOHYDRATEActive
Quantity: 5000 mg in 100 mL
Code: LX22YL083G
Classification: ACTIB
Dextrose Monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-240
Application NumberANDA207449
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextrose Monohydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 24, 2022
FDA Product Classification
INGREDIENTS (2)
DEXTROSE MONOHYDRATEActive
Quantity: 25000 mg in 500 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Dextrose Monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-234
Application NumberANDA207449
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextrose Monohydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 24, 2022
FDA Product Classification
INGREDIENTS (1)
DEXTROSE MONOHYDRATEActive
Quantity: 2500 mg in 50 mL
Code: LX22YL083G
Classification: ACTIB
Dextrose Monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-238
Application NumberANDA207449
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextrose Monohydrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 24, 2022
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEActive
Quantity: 12500 mg in 250 mL
Code: LX22YL083G
Classification: ACTIB