sodium sulfate, potassium sulfate, and magnesium sulfate bowel prep kit

Generic: sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium sulfate, potassium sulfate, and magnesium sulfate bowel prep kit
Generic Name sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4170
Product ID 51672-4170_494f52da-8ae6-6ec4-e063-6294a90a73a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206431
Listing Expiration 2027-12-31
Marketing Start 2024-03-27

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 516724170
Hyphenated Format 51672-4170

Supplemental Identifiers

RxCUI
1001689 1120068
UPC
0351672417055
UNII
DE08037SAB 1K573LC5TV 36KCS0R750

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 bowel prep kit (source: ndc)
Generic Name sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate (source: ndc)
Application Number ANDA206431 (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 in 1 CARTON (51672-4170-5) / 177 mL in 1 BOTTLE
source: ndc

Packages (1)

Ingredients (3)

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "494f52da-8ae6-6ec4-e063-6294a90a73a6", "openfda": {"upc": ["0351672417055"], "unii": ["DE08037SAB", "1K573LC5TV", "36KCS0R750"], "rxcui": ["1001689", "1120068"], "spl_set_id": ["4adeeb11-0f3a-47d8-a664-376df50b05f2"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (51672-4170-5)  / 177 mL in 1 BOTTLE", "package_ndc": "51672-4170-5", "marketing_start_date": "20240327"}], "brand_name": "Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit", "product_id": "51672-4170_494f52da-8ae6-6ec4-e063-6294a90a73a6", "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": "51672-4170", "generic_name": "sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit", "active_ingredients": [{"name": "MAGNESIUM SULFATE, UNSPECIFIED FORM", "strength": "1.6 g/177mL"}, {"name": "POTASSIUM SULFATE", "strength": "3.13 g/177mL"}, {"name": "SODIUM SULFATE ANHYDROUS", "strength": "17.5 g/177mL"}], "application_number": "ANDA206431", "marketing_category": "ANDA", "marketing_start_date": "20240327", "listing_expiration_date": "20271231"}