Prescription Drug Information: Magnesium Sulfate (Page 2 of 2)

HOW SUPPLIED

Magnesium Sulfate in Water for Injection is supplied in single-dose bag with an aluminum overwrap. The infusion bags and ports are not made with natural rubber latex.

Magnesium Sulfate in Water for Injection is available as follows:

NDC No.

Packaging Configuration

Size Container

Total Magnesium Sulfate**

Total Magnesium Ion

Magnesium Sulfate** Concentration

Magnesium Ion Concentration

Osmolarity (calc.)

44567-421-24

1 single-dose bag

100 mL

4 g

32.5 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/
Liter

44567-421-24

24 bags per carton

44567-422-24

1 single-dose bag

500 mL

20 g

162.3 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/
Liter

44567-422-24

24 bags per carton

44567-423-10

1 single-dose bag

1000 mL

40 g

325 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/
Liter

44567-423-10

10 bags per carton

44567-420-24

1 single-dose bag

50 mL*

2 g

16.25 mEq

4% (40 mg/mL)

16.25 mEq/100 mL

325 mOsmol/
Liter

44567-420-24

24 bags per carton

44567-424-24

1 single-dose bag

50 mL*

4 g

32.5 mEq

8% (80 mg/mL)

32.5 mEq/100 mL

649 mOsmol/
Liter

44567-424-24

24 bags per carton

* Partial fill container 50 mL volume in 100 mL container.

** As the heptahydrate.

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.

REFERENCES

1. Yokoyama K, Takahashi N, Yada Y. Prolonged maternal magnesium administration and bone metabolism in neonates. Early Human Dev. 2010; 86(3):187-91. Epub 2010 Mar 12.

2. Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal magnesium toxicity. J Perinatol. 2006; 26(6):371-4.

3. 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.

4. 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.

5. 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.

6. 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.

7. Santi MD, Henry GW, Douglas GL. Magnesium sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthop. 1994; 14(2):249-53.

8. Holocomb WL, Shackelford GD, Petrie RH. Magnesium tocolysis and neonatal bone abnormalities: a controlled study. Obstet Gynecol. 1991; 78(4):611-4.

9. Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.

10. Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with magnesium sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.

11. 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.

12. Riaz M, Porat R, Brodsky NL, et al. The effect of maternal magnesium sulfate treatment on newborns: a prospective controlled study. J Perinatol. 1998; 18(6 pt 1):449-54.

Manufactured for:

WG Critical Care, LLC

Paramus, NJ 07652

Made in Switzerland

Revised: September 2018

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 44567-421-24

Magnesium Sulfate in Water for Injection

(0.325 mEq Mg++/mL) (40 mg/mL)

4 g Total

For Intravenous Infusion Use

Rx only

WGCC Magnesium Sulfate in WFI 4 g (40 mg) bag label image
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 44567-422-24

Magnesium Sulfate in Water for Injection

(0.325 mEq Mg++/mL) (40 mg/mL)

20 g Total

For Intravenous Infusion Use

Rx only

Magnesium Sulfate in WFI 20 g -- 40 mg bag label image
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 44567-423-10

Magnesium Sulfate in Water for Injection

(0.325 mEq Mg++/mL) (40 mg/mL)

40 g Total

For Intravenous Infusion Use

Rx only

Magnesium Sulfate in WFI 40 g -- 40 mg bag label image
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 44567-420-24

Magnesium Sulfate in Water for Injection

(0.325 mEq Mg++/mL) (40 mg/mL)

2 g Total

For Intravenous Infusion Use

Rx only

Magnesium Sulfate in WFI 2 g -- 40 mg bag label image
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 44567-424-24

Magnesium Sulfate in Water for Injection

(0.65 mEq Mg++/mL) (80 mg/mL)

4 g Total

For Intravenous Infusion Use

Rx only

Magnesium Sulfate in WFI 4 g 80 mg bag label image
(click image for full-size original)
MAGNESIUM SULFATE
magnesium sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-421
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM SULFATE HEPTAHYDRATE (MAGNESIUM CATION) MAGNESIUM SULFATE HEPTAHYDRATE 4 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-421-24 24 POUCH in 1 CARTON contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CARTON (44567-421-24) and contains a BAG
1 100 mL in 1 BAG This package is contained within a POUCH and a CARTON (44567-421-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207350 01/09/2018
MAGNESIUM SULFATE
magnesium sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-422
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM SULFATE HEPTAHYDRATE (MAGNESIUM CATION) MAGNESIUM SULFATE HEPTAHYDRATE 20 g in 500 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-422-24 24 BAG in 1 CARTON contains a BAG
1 500 mL in 1 BAG This package is contained within the CARTON (44567-422-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207350 01/09/2018
MAGNESIUM SULFATE
magnesium sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-423
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 g in 1000 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-423-10 10 BAG in 1 CARTON contains a BAG
1 1000 mL in 1 BAG This package is contained within the CARTON (44567-423-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207350 01/09/2018
MAGNESIUM SULFATE
magnesium sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-420
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM SULFATE HEPTAHYDRATE (MAGNESIUM CATION) MAGNESIUM SULFATE HEPTAHYDRATE 2 g in 50 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-420-24 24 POUCH in 1 CARTON contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CARTON (44567-420-24) and contains a BAG
1 50 mL in 1 BAG This package is contained within a POUCH and a CARTON (44567-420-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207350 01/09/2018
MAGNESIUM SULFATE
magnesium sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-424
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM SULFATE HEPTAHYDRATE (MAGNESIUM CATION) MAGNESIUM SULFATE HEPTAHYDRATE 4 g in 50 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-424-24 24 POUCH in 1 CARTON contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CARTON (44567-424-24) and contains a BAG
1 50 mL in 1 BAG This package is contained within a POUCH and a CARTON (44567-424-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207350 01/09/2018
Labeler — WG Critical Care, LLC (829274633)
Registrant — HQ Specialty Pharma Corporation (962364332)
Establishment
Name Address ID/FEI Operations
InfoRLife 481732753 MANUFACTURE (44567-421), MANUFACTURE (44567-422), MANUFACTURE (44567-423), MANUFACTURE (44567-420), MANUFACTURE (44567-424)

Revised: 07/2021 WG Critical Care, LLC

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