SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Product NDC
52536-175
11-digit product format
525360175
Labeler code
52536
Product ID
52536-175_f269929e-c2ff-4288-9d3b-7770bcb5a498
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium sulfate, potassium sulfate, magnesium sulfate
Dosage form
SOLUTION, CONCENTRATE
Route
ORAL
Labeler
Wilshire Pharmaceuticals, Inc.
Application
NDA022372
Marketing category
NDA
Marketing start
2026-04-15
Substance
MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM SULFATE; SODIUM SULFATE
Active strength
1.6; 3.13; 17.5 g/mL; g/mL; g/mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], 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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE, UNSPECIFIED FORM1.6 g/mL
POTASSIUM SULFATE3.13 g/mL
SODIUM SULFATE17.5 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDE08037SAB, 1K573LC5TV, 0YPR65R21J
Rxcui1001689, 1120068, 2390767

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52536-175-01SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE2 in 1 CARTONSOLUTION, CONCENTRATE21
52536-175-01SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE177.4 mL in 1 BOTTLE, PLASTICSOLUTION, CONCENTRATE177.41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2390767{2 (355 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } PackGPCKf269929e-c2ff-4288-9d3b-7770bcb5a4981
1001689{2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } PackGPCKf269929e-c2ff-4288-9d3b-7770bcb5a4981
2390767{2 (12 OZ magnesium sulfate 1.2 GM / potassium sulfate 2.35 GM / sodium sulfate 13.13 GM Oral Solution) } PackPSNf269929e-c2ff-4288-9d3b-7770bcb5a4981
10016892 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) PackPSNf269929e-c2ff-4288-9d3b-7770bcb5a4981
1120068magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM in 177 mL Oral SolutionPSNf269929e-c2ff-4288-9d3b-7770bcb5a4981
1120068magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral SolutionSCDf269929e-c2ff-4288-9d3b-7770bcb5a4981
1120068Magnesium Sulfate 0.0277 MEQ/ML / K+ sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral SolutionSYf269929e-c2ff-4288-9d3b-7770bcb5a4981
1120068Magnesium Sulfate 0.0277 MEQ/ML / Pot sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral SolutionSYf269929e-c2ff-4288-9d3b-7770bcb5a4981
1120068magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM per 177 ML Oral SolutionSYf269929e-c2ff-4288-9d3b-7770bcb5a4981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
52536-175-01525360175012 BOTTLE, PLASTIC in 1 CARTON (52536-175-01) / 177.4 mL in 1 BOTTLE, PLASTIC2026-04-15NoNoHistorical