Package 64380-116-01

Brand: sodium sulfate, potassium sulfate and magnesium sulfate oral

Generic: sodium sulfate, potassium sulfate and magnesium sulfate oral
NDC Package

Package Facts

Identity

Package NDC 64380-116-01
Digits Only 6438011601
Product NDC 64380-116
Description

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

Marketing

Marketing Status
Marketed Since 2024-01-17
Brand sodium sulfate, potassium sulfate and magnesium sulfate oral
Generic sodium sulfate, potassium sulfate and magnesium sulfate oral
Sample Package No

Linked Drug Pages (1)

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"}