magnesium sulfate

Generic: magnesium sulfate heptahydrate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name magnesium sulfate
Generic Name magnesium sulfate heptahydrate
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

magnesium sulfate heptahydrate 2 g/50mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-396
Product ID 68083-396_4166c4fd-2951-4ab0-ab2a-6da9dd39927e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213917
Listing Expiration 2026-12-31
Marketing Start 2020-07-10

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 68083396
Hyphenated Format 68083-396

Supplemental Identifiers

RxCUI
1658259 1658262
UPC
0368083397012 0368083396015
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 ANDA213917 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 g/50mL
source: ndc
Packaging
  • 24 POUCH in 1 CASE (68083-396-01) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
source: ndc

Packages (1)

68083-396-01 24 POUCH in 1 CASE (68083-396-01) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Ingredients (1)

magnesium sulfate heptahydrate (2 g/50mL)

Linked Drug Pages (1)

MAGNESIUM SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4166c4fd-2951-4ab0-ab2a-6da9dd39927e", "openfda": {"upc": ["0368083397012", "0368083396015"], "unii": ["SK47B8698T"], "rxcui": ["1658259", "1658262"], "spl_set_id": ["a9e706ac-9c5f-4b14-b277-53dee195ffc6"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CASE (68083-396-01)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG", "package_ndc": "68083-396-01", "marketing_start_date": "20200710"}], "brand_name": "MAGNESIUM SULFATE", "product_id": "68083-396_4166c4fd-2951-4ab0-ab2a-6da9dd39927e", "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": "68083-396", "generic_name": "MAGNESIUM SULFATE HEPTAHYDRATE", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MAGNESIUM SULFATE", "active_ingredients": [{"name": "MAGNESIUM SULFATE HEPTAHYDRATE", "strength": "2 g/50mL"}], "application_number": "ANDA213917", "marketing_category": "ANDA", "marketing_start_date": "20200710", "listing_expiration_date": "20261231"}