NDC 51662-1235

50% MAGNESIUM SULFATE

50% Magnesium Sulfate

50% MAGNESIUM SULFATE is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co. Llc, Dba Health First. The primary component is Magnesium Sulfate Heptahydrate.

Product ID51662-1235_7446d09b-10ff-7765-e053-2a91aa0a56a8
NDC51662-1235
Product TypeHuman Prescription Drug
Proprietary Name50% MAGNESIUM SULFATE
Generic Name50% Magnesium Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-08-25
Marketing CategoryANDA / ANDA
Application NumberANDA075151
Labeler NameHF Acquisition Co. LLC, DBA Health First
Substance NameMAGNESIUM SULFATE HEPTAHYDRATE
Active Ingredient Strength500 mg/mL
Pharm ClassesCalculi 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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51662-1235-1

1 SYRINGE, PLASTIC in 1 CARTON (51662-1235-1) > 10 mL in 1 SYRINGE, PLASTIC
Marketing Start Date2018-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51662-1235-1 [51662123501]

50% MAGNESIUM SULFATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-25
Inactivation Date2020-01-31
Reactivation Date2020-02-07

Drug Details

Active Ingredients

IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE500 mg/mL

OpenFDA Data

SPL SET ID:7446d09b-10fe-7765-e053-2a91aa0a56a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 829762
  • Pharmacological Class

    • 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]

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