sodium sulfate, potassium sulfate, and magnesium sulfate (69452-428)

Drug Facts

Product Profile

Brand Name sodium sulfate, potassium sulfate, and magnesium sulfate

Generic Name sodium sulfate, potassium sulfate, and magnesium sulfate

Labeler bionpharma inc.,

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

magnesium sulfate anhydrous 1.6 g/177mL, potassium sulfate 3.13 g/177mL, sodium sulfate 17.5 g/177mL

Manufacturer

Bionpharma Inc.,

Identifiers & Regulatory

Product NDC 69452-428

Product ID 69452-428_4aa6b3b1-3213-5212-e063-6394a90a3d18

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204135

Listing Expiration 2027-12-31

Marketing Start 2025-04-15

Pharmacologic Class

Classes

calculi dissolution agent [epc] increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] inhibition small intestine fluid/electrolyte absorption [pe] magnesium ion exchange activity [moa] osmotic activity [moa] osmotic laxative [epc] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452428

Hyphenated Format 69452-428

Supplemental Identifiers

RxCUI

1001689 1120068

UPC

0369452428979

UNII

ML30MJ2U7I 1K573LC5TV 0YPR65R21J

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sodium sulfate, potassium sulfate, and magnesium sulfate (source: ndc)

Generic Name sodium sulfate, potassium sulfate, and magnesium sulfate (source: ndc)

Application Number ANDA204135 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1.6 g/177mL
3.13 g/177mL
17.5 g/177mL

source: ndc

Packaging

2 BOTTLE, PLASTIC in 1 KIT (69452-428-62) / 177 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (1)

69452-428-62 2 BOTTLE, PLASTIC in 1 KIT (69452-428-62) / 177 mL in 1 BOTTLE, PLASTIC

Ingredients (3)

magnesium sulfate anhydrous (1.6 g/177mL) potassium sulfate (3.13 g/177mL) sodium sulfate (17.5 g/177mL)

Linked Drug Pages (1)

sodium sulfate, potassium sulfate, and magnesium sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4aa6b3b1-3213-5212-e063-6394a90a3d18", "openfda": {"upc": ["0369452428979"], "unii": ["ML30MJ2U7I", "1K573LC5TV", "0YPR65R21J"], "rxcui": ["1001689", "1120068"], "spl_set_id": ["31d13799-0931-7735-e063-6294a90a6d02"], "manufacturer_name": ["Bionpharma Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PLASTIC in 1 KIT (69452-428-62)  / 177 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69452-428-62", "marketing_start_date": "20250415"}], "brand_name": "sodium sulfate, potassium sulfate, and magnesium sulfate", "product_id": "69452-428_4aa6b3b1-3213-5212-e063-6394a90a3d18", "dosage_form": "SOLUTION", "pharm_class": ["Calculi 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]"], "product_ndc": "69452-428", "generic_name": "sodium sulfate, potassium sulfate, and magnesium sulfate", "labeler_name": "Bionpharma Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sodium sulfate, potassium sulfate, and magnesium sulfate", "active_ingredients": [{"name": "MAGNESIUM SULFATE ANHYDROUS", "strength": "1.6 g/177mL"}, {"name": "POTASSIUM SULFATE", "strength": "3.13 g/177mL"}, {"name": "SODIUM SULFATE", "strength": "17.5 g/177mL"}], "application_number": "ANDA204135", "marketing_category": "ANDA", "marketing_start_date": "20250415", "listing_expiration_date": "20271231"}