Potassium Chloride in Dextrose and Sodium Chloride
INTRAVENOUS SOLUTIONSWITH POTASSIUM CHLORIDE
Approved
Approval ID
d8ee14e9-6733-4813-9f21-2b043a5f7188
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2021
Manufacturers
FDA
ICU Medical Inc.
DUNS: 118380146
Products 7
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 Code0990-7993
Application NumberNDA018362
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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
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 Code0990-7107
Application NumberNDA019691
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEActive
Quantity: 9 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 1.49 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7902
Application NumberNDA018362
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEActive
Quantity: 4.5 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 1.49 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7109
Application NumberNDA019691
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEActive
Quantity: 9 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.98 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
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 Code0990-7901
Application NumberNDA018365
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 2.25 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
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 Code0990-7904
Application NumberNDA018362
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 2.98 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
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 Code0990-7903
Application NumberNDA018362
Product Classification
M
Marketing Category
C73594
G
Generic Name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEActive
Quantity: 4.5 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 50 g in 1000 mL
Code: LX22YL083G
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 2.24 g in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT