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Magnesium Sulfate

Approved
Approval ID

d4b5863a-efb9-4551-a9ad-2b06e8666d87

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 17, 2023

Manufacturers
FDA

Hospira, Inc.

DUNS: 141588017

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

magnesium sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-1754
Application NumberANDA075151
Product Classification
M
Marketing Category
C73584
G
Generic Name
magnesium sulfate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 17, 2023
FDA Product Classification

INGREDIENTS (4)

SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MAGNESIUM SULFATE HEPTAHYDRATEActive
Quantity: 500 mg in 1 mL
Code: SK47B8698T
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/17/2023

PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

10 mL

NDC 0409-1754-15
Rx only

Single-dose syringe

Magnesium
Sulfate
Injection, USP
50%

5 g/10 mL (500 mg/mL)
(4 mEq Mg++/mL)

For intravenous or
intramuscular use

Ansyr™
Single-dose syringe

CAUTION:
Must be diluted
before
intravenous use.

Hospira

LOT #####AA
EXP DMMMYYYY

◀ PRESS AND PULL TO OPEN ▶

PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 7/17/2023

HOW SUPPLIED

Magnesium Sulfate Injection, USP is supplied in single-dose containers as follows:

NDC No.

Container

Total

Amount

Concentration

mEq

Mg**++****/mL**

0409-1754-10

Ansyr™

Plastic Syringe

5 g/10 mL

50%

4 mEq/mL

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]

REFERENCES SECTION

LOINC: 34093-5Updated: 7/17/2023

REFERENCES

Yokoyama K, Takahashi N, Yada Y. Prolonged maternal magnesium administration and bone metabolism in neonates. Early Hum Dev. 2010;86(3):187-91. Epub 2010 Mar 12.
Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal magnesium toxicity. J. Perinatol. 2006; 26(6):371-4.
Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of magnesium sulfate tocolysis. Acta Obstet Gynecol Scan. 2006;85(9):1099-103.
Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received magnesium sulphate for tocolysis of premature labor. Pediatr Radiol. 2004;34(5):384-6. Epub 2004 Feb 18.
Matsuda Y, Maeda Y, Ito M, et al. Effect of magnesium sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest. 1997;44(2):82-8.
Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous magnesium sulfate therapy on neonatal calcium metabolism and bone mineral content. Gynecol Obstet Invest. 1997;43(4):236-41.
Santi MD, Henry GW, Douglas GL. Magnesium sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthrop. 1994;14(2):249-53.
Holcomb WL, Shackelford GD, Petrie RH. Magnesium tocolysis and neonatal bone abnormalities; a controlled study. Obstet Gynecol. 1991; 78(4):611-4.
Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.
Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with magnesium sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.
McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of magnesium sulfate treatment on perinatal calcium metabolism. II. Neonatal responses. Obstet Gynecol. 1980; 56(5): 595-600.
Riaz M, Porat R, Brodsky NL, et al. The effects of maternal magnesium sulfate treatment on newborns: a prospective controlled study. J. Perinatol. 1998;18(6 pt 1):449-54.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira Logo

LAB-1024-4.0

Revised: 05/2020

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Magnesium Sulfate - FDA Drug Approval Details