magnesium sulfate (63323-642)

Drug Facts

Product Profile

Brand Name magnesium sulfate

Generic Name magnesium sulfate heptahydrate

Labeler fresenius kabi usa, llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS

Active Ingredients

magnesium sulfate heptahydrate 500 mg/mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-642

Product ID 63323-642_89d02988-a12e-4224-88f0-3f05f7ee324f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA019316

Listing Expiration 2026-12-31

Marketing Start 2016-01-29

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 63323642

Hyphenated Format 63323-642

Supplemental Identifiers

RxCUI

1658236 1658245

UPC

0363323642020 0363323642013

UNII

SK47B8698T

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 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 (63323-642-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-642-01)
25 VIAL, SINGLE-DOSE in 1 CARTON (63323-642-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-642-02)

source: ndc

Packages (2)

63323-642-20 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-642-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-642-01) 63323-642-50 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-642-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-642-02)

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": "89d02988-a12e-4224-88f0-3f05f7ee324f", "openfda": {"upc": ["0363323642020", "0363323642013"], "unii": ["SK47B8698T"], "rxcui": ["1658236", "1658245"], "spl_set_id": ["77f70e00-3934-4fd9-a581-4cf3df8c42d2"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-642-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-642-01)", "package_ndc": "63323-642-20", "marketing_start_date": "20160129"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-642-50)  / 50 mL in 1 VIAL, SINGLE-DOSE (63323-642-02)", "package_ndc": "63323-642-50", "marketing_start_date": "20160129"}], "brand_name": "Magnesium Sulfate", "product_id": "63323-642_89d02988-a12e-4224-88f0-3f05f7ee324f", "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": "63323-642", "generic_name": "MAGNESIUM SULFATE HEPTAHYDRATE", "labeler_name": "Fresenius Kabi USA, LLC", "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": "20160129", "listing_expiration_date": "20261231"}