sodium sulfate, potassium sulfate and magnesium sulfate oral

Generic: sodium sulfate, potassium sulfate and magnesium sulfate oral

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium sulfate, potassium sulfate and magnesium sulfate oral
Generic Name sodium sulfate, potassium sulfate and magnesium sulfate oral
Labeler strides pharma science limited
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-116
Product ID 64380-116_2c66ebff-4389-49f9-a6ed-39d7de46dcb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215469
Listing Expiration 2026-12-31
Marketing Start 2024-01-17

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 64380116
Hyphenated Format 64380-116

Supplemental Identifiers

RxCUI
1120068
UNII
DE08037SAB 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 oral (source: ndc)
Generic Name sodium sulfate, potassium sulfate and magnesium sulfate oral (source: ndc)
Application Number ANDA215469 (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 (64380-116-01) / 177 mL in 1 BOTTLE (64380-116-02)
source: ndc

Packages (1)

64380-116-01 2 BOTTLE in 1 CARTON (64380-116-01) / 177 mL in 1 BOTTLE (64380-116-02)

Ingredients (3)

magnesium sulfate, unspecified form (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 Oral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c66ebff-4389-49f9-a6ed-39d7de46dcb5", "openfda": {"unii": ["DE08037SAB", "1K573LC5TV", "0YPR65R21J"], "rxcui": ["1120068"], "spl_set_id": ["d48d8c59-68b9-4e28-86a4-eabf8b2003b0"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (64380-116-01)  / 177 mL in 1 BOTTLE (64380-116-02)", "package_ndc": "64380-116-01", "marketing_start_date": "20240117"}], "brand_name": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral", "product_id": "64380-116_2c66ebff-4389-49f9-a6ed-39d7de46dcb5", "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": "64380-116", "generic_name": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral", "active_ingredients": [{"name": "MAGNESIUM SULFATE, UNSPECIFIED FORM", "strength": "1.6 g/177mL"}, {"name": "POTASSIUM SULFATE", "strength": "3.13 g/177mL"}, {"name": "SODIUM SULFATE", "strength": "17.5 g/177mL"}], "application_number": "ANDA215469", "marketing_category": "ANDA", "marketing_start_date": "20240117", "listing_expiration_date": "20261231"}