Magnesium Sulfate

Product NDC
51754-1000
11-digit product format
517541000
Labeler code
51754
Product ID
51754-1000_f227d408-1656-435e-bfc7-9ad7423706a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
ANDA206039
Marketing category
ANDA
Marketing start
2014-02-23
Marketing end
0000-00-00
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
500 mg/mL
Pharmacologic classes
Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51754-1000-42025-12-03C16284748780-12cef2736-8cd0-d83d-e063-dadaa90ab31f4ce43b41-b48b-4882-8617-6d8380a9fb72
51754-1000-42025-01-30C16284748780-12cef2736-8cd0-d83d-e063-dadaa90ab31f4ce43b41-b48b-4882-8617-6d8380a9fb72

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-1000-4ML - Milliliter51754-10000cbcad4c-4490-4757-9079-dd4cf9e4d2d112018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-1000MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]2Legacy NDC20180827_4ce43b41-b48b-4882-8617-6d8380a9fb72.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51754-1000-45175410000425 VIAL, SINGLE-DOSE in 1 TRAY (51754-1000-4) > 10 mL in 1 VIAL, SINGLE-DOSE2014-02-230000-00-00NoNoCurrent