magnesium sulfate

Generic: magnesium sulfate heptahydrate

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name magnesium sulfate
Generic Name magnesium sulfate heptahydrate
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

magnesium sulfate heptahydrate 500 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-064
Product ID 84549-064_386d55c9-aead-5597-e063-6294a90a0afe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019316
Listing Expiration 2026-12-31
Marketing Start 2000-08-08

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 84549064
Hyphenated Format 84549-064

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
  • 2 mL in 1 VIAL, SINGLE-DOSE (84549-064-03)
source: ndc

Packages (1)

84549-064-03 2 mL in 1 VIAL, SINGLE-DOSE (84549-064-03)

Ingredients (1)

magnesium sulfate heptahydrate (500 mg/mL)

Linked Drug Pages (2)

Magnesium Sulfate ndc-match (0.9) Magnesium Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "386d55c9-aead-5597-e063-6294a90a0afe", "openfda": {"unii": ["SK47B8698T"], "rxcui": ["1658244"], "spl_set_id": ["386d55c9-aeac-5597-e063-6294a90a0afe"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL, SINGLE-DOSE (84549-064-03)", "package_ndc": "84549-064-03", "marketing_start_date": "20250625"}], "brand_name": "Magnesium Sulfate", "product_id": "84549-064_386d55c9-aead-5597-e063-6294a90a0afe", "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": "84549-064", "generic_name": "MAGNESIUM SULFATE HEPTAHYDRATE", "labeler_name": "ProPharma Distribution", "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": "20000808", "listing_expiration_date": "20261231"}