Potassium Chloride in Dextrose and Sodium Chloride
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE
Approved
Approval ID
fe5b5182-c859-4c74-b2e0-467be5b2e329
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-146
Application NumberANDA213523
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 25, 2022
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 2.24 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 4.5 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-142
Application NumberANDA213523
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 25, 2022
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 4.5 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.745 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-144
Application NumberANDA213523
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 25, 2022
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 4.5 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 1.49 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-150
Application NumberANDA213523
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 25, 2022
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEActive
Quantity: 25 g in 500 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 2.25 g in 500 mL
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.745 g in 500 mL
Code: 660YQ98I10
Classification: ACTIB
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-148
Application NumberANDA213523
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 25, 2022
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.98 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 4.5 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB