sodium sulfate, potassium sulfate, magnesium sulfate (43386-700)

Drug Facts

Product Profile

Brand Name sodium sulfate, potassium sulfate, magnesium sulfate

Generic Name sodium sulfate, potassium sulfate, magnesium sulfate

Labeler lupin pharmaceuticals, 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

Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43386-700

Product ID 43386-700_9fffaef0-0578-452d-a365-166b183d8e00

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202511

Listing Expiration 2026-12-31

Marketing Start 2022-12-30

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 43386700

Hyphenated Format 43386-700

Supplemental Identifiers

RxCUI

1001689 1120068

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, magnesium sulfate (source: ndc)

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

Application Number ANDA202511 (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 (43386-700-83) / 177 mL in 1 BOTTLE

source: ndc

Packages (1)

43386-700-83 2 BOTTLE in 1 CARTON (43386-700-83) / 177 mL in 1 BOTTLE

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, MAGNESIUM SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "9fffaef0-0578-452d-a365-166b183d8e00", "openfda": {"unii": ["ML30MJ2U7I", "1K573LC5TV", "0YPR65R21J"], "rxcui": ["1001689", "1120068"], "spl_set_id": ["d4883657-d27d-4056-a567-5fb12d5e05d1"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (43386-700-83)  / 177 mL in 1 BOTTLE", "package_ndc": "43386-700-83", "marketing_start_date": "20221230"}], "brand_name": "SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE", "product_id": "43386-700_9fffaef0-0578-452d-a365-166b183d8e00", "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": "43386-700", "generic_name": "sodium sulfate, potassium sulfate, magnesium sulfate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SODIUM SULFATE, POTASSIUM SULFATE, 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": "ANDA202511", "marketing_category": "ANDA", "marketing_start_date": "20221230", "listing_expiration_date": "20261231"}