Elliotts B
ELLIOTTS B SOLUTION (buffered intrathecal electrolyte/dextrose injection) Rx Only
Approved
Approval ID
b1e83fb1-7f51-41b7-a1eb-495414bbf1f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2012
Manufacturers
FDA
QOL Medical, LLC
DUNS: 140026258
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
NDC Product Code67871-007
Application NumberNDA020577
Marketing CategoryC73594
Route of AdministrationINTRATHECAL
Effective DateMarch 20, 2012
Generic Namesodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate
INGREDIENTS (8)
sodium chlorideActive
Quantity: 73 mg in 10 mL
Code: 451W47IQ8X
Classification: ACTIB
magnesium sulfateActive
Quantity: 3 mg in 10 mL
Code: DE08037SAB
Classification: ACTIB
sodium bicarbonateActive
Quantity: 19 mg in 10 mL
Code: 8MDF5V39QO
Classification: ACTIB
anhydrous dextroseActive
Quantity: 8 mg in 10 mL
Code: 5SL0G7R0OK
Classification: ACTIB
potassium chlorideActive
Quantity: 3 mg in 10 mL
Code: 660YQ98I10
Classification: ACTIB
WaterInactive
Quantity: 10 mL in 10 mL
Code: 059QF0KO0R
Classification: IACT
sodium phosphateActive
Quantity: 2 mg in 10 mL
Code: SE337SVY37
Classification: ACTIB
calcium chlorideActive
Quantity: 2 mg in 10 mL
Code: M4I0D6VV5M
Classification: ACTIB