magnesium sulfate

Generic: magnesium sulfate heptahydrate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name magnesium sulfate
Generic Name magnesium sulfate heptahydrate
Labeler remedyrepack inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

magnesium sulfate heptahydrate 500 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4375
Product ID 70518-4375_38c927fd-0698-9f0a-e063-6394a90a47a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019316
Listing Expiration 2026-12-31
Marketing Start 2025-06-28

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 705184375
Hyphenated Format 70518-4375

Supplemental Identifiers

RxCUI
1658244
UNII
SK47B8698T

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 magnesium sulfate (source: ndc)
Generic Name magnesium sulfate heptahydrate (source: ndc)
Application Number NDA019316 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (70518-4375-0) / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4375-1)
source: ndc

Packages (1)

70518-4375-0 25 VIAL, SINGLE-DOSE in 1 TRAY (70518-4375-0) / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4375-1)

Ingredients (1)

magnesium sulfate heptahydrate (500 mg/mL)

Linked Drug Pages (1)

Magnesium Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "38c927fd-0698-9f0a-e063-6394a90a47a9", "openfda": {"unii": ["SK47B8698T"], "rxcui": ["1658244"], "spl_set_id": ["8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (70518-4375-0)  / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4375-1)", "package_ndc": "70518-4375-0", "marketing_start_date": "20250628"}], "brand_name": "Magnesium Sulfate", "product_id": "70518-4375_38c927fd-0698-9f0a-e063-6394a90a47a9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["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]"], "product_ndc": "70518-4375", "generic_name": "MAGNESIUM SULFATE HEPTAHYDRATE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Magnesium Sulfate", "active_ingredients": [{"name": "MAGNESIUM SULFATE HEPTAHYDRATE", "strength": "500 mg/mL"}], "application_number": "NDA019316", "marketing_category": "NDA", "marketing_start_date": "20250628", "listing_expiration_date": "20261231"}