Lacellate Solution - 250
Lacellate Solution - 250
Approved
Approval ID
6fbfe1f7-3db1-4c9f-aafb-d336a563c9c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2022
Manufacturers
FDA
IT3 Medical LLC
DUNS: 079971231
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium chloride, potassium chloride, sodium lactate and calcium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70529-025
Application NumberNDA016682
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium chloride, potassium chloride, sodium lactate and calcium chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 6, 2018
FDA Product Classification
INGREDIENTS (5)
SODIUM LACTATEActive
Quantity: 310 mg in 100 mL
Code: TU7HW0W0QT
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: ACTIM
CALCIUM CHLORIDEActive
Quantity: 20 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT