Prescription Drug Information: MAGNESIUM SULFATE (Page 2 of 2)

HOW SUPPLIED

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows:

NDC 51662-1352-1 MAGNESIUM SULFATE IN WATER FOR INJECTION 2g/50mL (40mg/mL) 50mL BAG

NDC 51662-1352-2 MAGNESIUM SULFATE IN WATER FOR INJECTION 2g/50mL (40mg/mL) 50mL BAG IN A POUCH

NDC 51662-1352-3 MAGNESIUM SULFATE IN WATER FOR INJECTION 2g/50mL (40mg/mL) 50mL BAG IN A POUCH, 24 POUCHES IN A CASE

HF Acquisition Co LLC, DBA HealthFirst
11629 49th Pl W.

Mukilteo, WA 98275

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

PRINCIPAL DISPLAY PANEL-BAG LABEL

BAG LABEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL-LABELED BAG

LABELED BAG
(click image for full-size original)

PRINCIPAL DISPLAY PANEL-SERIALIZED LABELING ON BAG

RFID Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC 51662-1352-2 POUCH

NDC 51662-1352-2 POUCH

POUCH
(click image for full-size original)

BAG

BAG
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC 51662-1352-3 CASE

NDC 51662-1352-3 CASE

CASE
(click image for full-size original)

SERIALIZED RFID LABEL

RFID Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC 51662-1352-2 POUCH — August 29 2022 update

POUCH LABELING

POUCH LABELING
(click image for full-size original)

BAG LABEL

BAG LABEL
(click image for full-size original)
MAGNESIUM SULFATE
magnesium sulfate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1352(NDC:0409-6729)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM SULFATE HEPTAHYDRATE (MAGNESIUM CATION) MAGNESIUM SULFATE HEPTAHYDRATE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SULFURIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1352-1 50 mL in 1 BAG None
2 NDC:51662-1352-3 24 POUCH in 1 CASE contains a POUCH (51662-1352-2)
2 NDC:51662-1352-2 1 BAG in 1 POUCH This package is contained within the CASE (51662-1352-3) and contains a BAG
2 50 mL in 1 BAG This package is contained within a POUCH (51662-1352-2) and a CASE (51662-1352-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020309 12/21/2018
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1352)

Revised: 01/2024 HF Acquisition Co LLC, DBA HealthFirst

Page 2 of 2 1 2

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.