Elliotts B
ELLIOTTS B SOLUTION (buffered intrathecal electrolyte/dextrose injection) Rx Only
Approved
Approval ID
08036dbd-55b3-47b9-9890-000f253544f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2018
Manufacturers
FDA
Lukare Medical, LLC
DUNS: 062862393
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55792-007
Application NumberNDA020577
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateNovember 16, 2018
FDA Product Classification
INGREDIENTS (8)
sodium bicarbonateActive
Quantity: 19 mg in 10 mL
Code: 8MDF5V39QO
Classification: ACTIB
anhydrous dextroseActive
Quantity: 8 mg in 10 mL
Code: 5SL0G7R0OK
Classification: ACTIB
sodium chlorideActive
Quantity: 73 mg in 10 mL
Code: 451W47IQ8X
Classification: ACTIB
MAGNESIUM SULFATE, UNSPECIFIEDActive
Quantity: 3 mg in 10 mL
Code: DE08037SAB
Classification: ACTIB
calcium chlorideActive
Quantity: 2 mg in 10 mL
Code: M4I0D6VV5M
Classification: ACTIB
sodium phosphateActive
Quantity: 2 mg in 10 mL
Code: SE337SVY37
Classification: ACTIB
WaterInactive
Quantity: 10 mL in 10 mL
Code: 059QF0KO0R
Classification: IACT
potassium chlorideActive
Quantity: 3 mg in 10 mL
Code: 660YQ98I10
Classification: ACTIB