PRISMASOL

Product NDC
24571-105
11-digit product format
245710105
Labeler code
24571
Product ID
24571-105_37da3e2a-3a1a-1784-e063-6394a90a969f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcium chloride, magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Vantive US Healthcare LLC
Application
NDA021703
Marketing category
NDA
Marketing start
2006-10-25
Substance
ANHYDROUS DEXTROSE; CALCIUM CHLORIDE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Active strength
20; 3.68; 5.4; 3.05; .314; 3.09; 6.46 g/L; g/L; g/L; g/L; g/L; g/L; g/L
Pharmacologic classes
Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRISMASOL
Brand name suffix
BGK4/2.5
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANHYDROUS DEXTROSE20 g/L
CALCIUM CHLORIDE3.68 g/L
LACTIC ACID5.4 g/L
MAGNESIUM CHLORIDE3.05 g/L
POTASSIUM CHLORIDE.314 g/L
SODIUM BICARBONATE3.09 g/L
SODIUM CHLORIDE6.46 g/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM4I0D6VV5M, 33X04XA5AT, GR686LBA74, 02F3473H9O, 8MDF5V39QO, 451W47IQ8X, 660YQ98I10, 5SL0G7R0OK

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24571-105-052021-08-03C16284748780-1c7ccaba7-157e-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use PRISMASOL and PHOXILLUM safely and effectively. See full prescribing information for PRISMASOL and PHOXILLUM. PRISMASOL renal replacement solution PRISMASOL Initial U.S. Approval: 2006 PHOXILLUM renal replacement solution PHOXILLUM Initial U.S. Approval: 2015
24571-105-062021-08-03C16284748780-1c7ccaba7-157e-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use PRISMASOL and PHOXILLUM safely and effectively. See full prescribing information for PRISMASOL and PHOXILLUM. PRISMASOL renal replacement solution PRISMASOL Initial U.S. Approval: 2006 PHOXILLUM renal replacement solution PHOXILLUM Initial U.S. Approval: 2015
24571-105-052021-07-23C16284748780-1c7ccaba7-157e-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use PRISMASOL and PHOXILLUM safely and effectively. See full prescribing information for PRISMASOL and PHOXILLUM. PRISMASOL renal replacement solution PRISMASOL Initial U.S. Approval: 2006 PHOXILLUM renal replacement solution PHOXILLUM Initial U.S. Approval: 2015
24571-105-062021-07-23C16284748780-1c7ccaba7-157e-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use PRISMASOL and PHOXILLUM safely and effectively. See full prescribing information for PRISMASOL and PHOXILLUM. PRISMASOL renal replacement solution PRISMASOL Initial U.S. Approval: 2006 PHOXILLUM renal replacement solution PHOXILLUM Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24571-105-06PRISMASOLBGK4/2.52 in 1 CASEINJECTION235
24571-105-06PRISMASOLBGK4/2.55 L in 1 BAGINJECTION535

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24571-105PRISMASOL BGK0/2.5 (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, AND SODIUM BICARBONATE) INJECTION PRISMASOL BGK4/2.5 (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE) INJECTION PRISMASOL BGK2/3.5 (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE) INJECTION PRISMASOL BGK2/0 (MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE) INJECTION PRISMASOL B22GK4/0 (MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE) INJECTION PRISMASOL BK0/0/1.2 (MAGNESIUM CHLORIDE, LACTIC ACID, SODIUM CHLORIDE, AND SODIUM BICARBONATE) INJECTION PRISMASOL BGK4/0/1.2 (MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE) INJECTION PHOXILLUM BK4/2.5 (34Current NDC, Legacy NDC, 2 package rows20250423_7f675fee-8940-4ece-bb0c-75ac79d8708c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24571-105-06245710105062 BAG in 1 CASE (24571-105-06) / 5 L in 1 BAG2 bag2006-10-250000-00-00NoNoCurrent