magnesium sulfate (63323-064)

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 63323-064

Product ID 63323-064_ffd78b94-31e0-4a2e-86da-f8c70f5c1d40

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA019316

Listing Expiration 2027-12-31

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 63323064

Hyphenated Format 63323-064

Supplemental Identifiers

RxCUI

1658221 1658244

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, GLASS in 1 TRAY (63323-064-23) / 2 mL in 1 VIAL, GLASS (63323-064-21)

source: ndc

Packages (1)

63323-064-23 25 VIAL, GLASS in 1 TRAY (63323-064-23) / 2 mL in 1 VIAL, GLASS (63323-064-21)

Ingredients (1)

magnesium sulfate heptahydrate (500 mg/mL)

Linked Drug Pages (3)

Magnesium Sulfate ndc-match (0.9) 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": "ffd78b94-31e0-4a2e-86da-f8c70f5c1d40", "openfda": {"unii": ["SK47B8698T"], "rxcui": ["1658221", "1658244"], "spl_set_id": ["e921a46b-9a5b-4163-9c88-224247541f14"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, GLASS in 1 TRAY (63323-064-23)  / 2 mL in 1 VIAL, GLASS (63323-064-21)", "package_ndc": "63323-064-23", "marketing_start_date": "20000808"}], "brand_name": "Magnesium Sulfate", "product_id": "63323-064_ffd78b94-31e0-4a2e-86da-f8c70f5c1d40", "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": "63323-064", "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": "20000808", "listing_expiration_date": "20271231"}