LACTATED RINGERS AND DEXTROSE
LACTATED RINGER'S AND DEXTROSE
Approved
Approval ID
7791f2c5-c49a-2f58-e053-2a91aa0a06cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 20, 2020
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE, DEXTROSE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1229
Application NumberNDA017608
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE, DEXTROSE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 20, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM LACTATEActive
Quantity: 310 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 600 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 30 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 20 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1300
Application NumberNDA017641
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 20, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM LACTATEActive
Quantity: 310 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 20 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 30 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 600 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT