magnesium sulfate in 5% dextrose (63323-108)

Drug Facts

Product Profile

Brand Name magnesium sulfate in 5% dextrose

Generic Name magnesium sulfate heptahydrate

Labeler fresenius kabi usa, llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

magnesium sulfate heptahydrate 1 g/100mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-108

Product ID 63323-108_f4995ccf-053b-4e1f-af35-0db8c6659e64

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206486

Listing Expiration 2026-12-31

Marketing Start 2016-03-07

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 63323108

Hyphenated Format 63323-108

Supplemental Identifiers

RxCUI

829757

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 in 5% dextrose (source: ndc)

Generic Name magnesium sulfate heptahydrate (source: ndc)

Application Number ANDA206486 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

1 g/100mL

source: ndc

Packaging

24 BAG in 1 CASE (63323-108-26) / 100 mL in 1 BAG (63323-108-02)

source: ndc

Packages (1)

63323-108-26 24 BAG in 1 CASE (63323-108-26) / 100 mL in 1 BAG (63323-108-02)

Ingredients (1)

magnesium sulfate heptahydrate (1 g/100mL)

Linked Drug Pages (2)

Magnesium Sulfate in 5% Dextrose ndc-match (0.9) Magnesium Sulfate in 5% Dextrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "f4995ccf-053b-4e1f-af35-0db8c6659e64", "openfda": {"unii": ["SK47B8698T"], "rxcui": ["829757"], "spl_set_id": ["fdffb339-89d1-4495-97b7-d9422d68b3d5"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CASE (63323-108-26)  / 100 mL in 1 BAG (63323-108-02)", "package_ndc": "63323-108-26", "marketing_start_date": "20160307"}], "brand_name": "Magnesium Sulfate in 5% Dextrose", "product_id": "63323-108_f4995ccf-053b-4e1f-af35-0db8c6659e64", "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": "63323-108", "generic_name": "Magnesium Sulfate Heptahydrate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Magnesium Sulfate in 5% Dextrose", "active_ingredients": [{"name": "MAGNESIUM SULFATE HEPTAHYDRATE", "strength": "1 g/100mL"}], "application_number": "ANDA206486", "marketing_category": "ANDA", "marketing_start_date": "20160307", "listing_expiration_date": "20261231"}