magnesium sulfate

Generic: magnesium sulfate heptahydrate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name magnesium sulfate
Generic Name magnesium sulfate heptahydrate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

magnesium sulfate heptahydrate 40 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-106
Product ID 63323-106_48486022-130e-4a6a-87e7-db7c53eb5e75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206485
Listing Expiration 2026-12-31
Marketing Start 2016-03-15

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 63323106
Hyphenated Format 63323-106

Supplemental Identifiers

RxCUI
829734 1658259 1658262 1658264 1658265
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 ANDA206485 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 24 BAG in 1 CASE (63323-106-01) / 100 mL in 1 BAG (63323-106-00)
  • 24 BAG in 1 CASE (63323-106-05) / 50 mL in 1 BAG (63323-106-02)
  • 24 BAG in 1 CASE (63323-106-10) / 1000 mL in 1 BAG
  • 24 BAG in 1 CASE (63323-106-15) / 500 mL in 1 BAG
source: ndc

Packages (4)

63323-106-01 24 BAG in 1 CASE (63323-106-01) / 100 mL in 1 BAG (63323-106-00) 63323-106-05 24 BAG in 1 CASE (63323-106-05) / 50 mL in 1 BAG (63323-106-02) 63323-106-10 24 BAG in 1 CASE (63323-106-10) / 1000 mL in 1 BAG 63323-106-15 24 BAG in 1 CASE (63323-106-15) / 500 mL in 1 BAG

Ingredients (1)

magnesium sulfate heptahydrate (40 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": ["INTRAVENOUS"], "spl_id": "48486022-130e-4a6a-87e7-db7c53eb5e75", "openfda": {"unii": ["SK47B8698T"], "rxcui": ["829734", "1658259", "1658262", "1658264", "1658265"], "spl_set_id": ["fef9e18c-5210-4090-b564-4950ebe461c0"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CASE (63323-106-01)  / 100 mL in 1 BAG (63323-106-00)", "package_ndc": "63323-106-01", "marketing_start_date": "20160315"}, {"sample": false, "description": "24 BAG in 1 CASE (63323-106-05)  / 50 mL in 1 BAG (63323-106-02)", "package_ndc": "63323-106-05", "marketing_start_date": "20160315"}, {"sample": false, "description": "24 BAG in 1 CASE (63323-106-10)  / 1000 mL in 1 BAG", "package_ndc": "63323-106-10", "marketing_start_date": "20160315"}, {"sample": false, "description": "24 BAG in 1 CASE (63323-106-15)  / 500 mL in 1 BAG", "package_ndc": "63323-106-15", "marketing_start_date": "20160315"}], "brand_name": "magnesium sulfate", "product_id": "63323-106_48486022-130e-4a6a-87e7-db7c53eb5e75", "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": "63323-106", "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": "40 mg/mL"}], "application_number": "ANDA206485", "marketing_category": "ANDA", "marketing_start_date": "20160315", "listing_expiration_date": "20261231"}