NDC 43386-700

SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE

Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate

SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Magnesium Sulfate Anhydrous; Potassium Sulfate; Sodium Sulfate.

Product ID43386-700_09357de7-a343-4651-ae47-41994a1a2c7d
NDC43386-700
Product TypeHuman Prescription Drug
Proprietary NameSODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE
Generic NameSodium Sulfate, Potassium Sulfate, Magnesium Sulfate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2022-12-30
Marketing CategoryANDA /
Application NumberANDA202511
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameMAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE
Active Ingredient Strength2 g/177mL; g/177mL; g/177mL
Pharm ClassesCalculi Dissolution Agent [EPC], 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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 43386-700-83

2 BOTTLE in 1 CARTON (43386-700-83) > 177 mL in 1 BOTTLE
Marketing Start Date2022-12-30
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE" or generic name "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate"

NDCBrand NameGeneric Name
40032-700SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATEsodium sulfate, potassium sulfate, magnesium sulfate
43386-700SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATEsodium sulfate, potassium sulfate, magnesium sulfate
10572-012SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEsodium sulfate, potassium sulfate, magnesium sulfate
10572-112SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEsodium sulfate, potassium sulfate, magnesium sulfate
52268-012SUPREP Bowel Prepsodium sulfate, potassium sulfate, magnesium sulfate
52268-112SUPREP Bowel Prepsodium sulfate, potassium sulfate, magnesium sulfate

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