ZINC SULFATE Solution for injection Ref.[51049] Active ingredients: Zinc sulfate

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

Zinc Sulfate Injection, USP is a sterile, clear, colorless solution, essentially free from visible particles intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition.

10 mg per 10 mL Pharmacy Bulk Package vial: Each mL contains 1 mg of zinc present as a 2.46 mg of zinc sulfate and water for injection, q.s.

30 mg per 10 mL Pharmacy Bulk Package vial: Each mL contains 3 mg of zinc present as 7.41 mg of zinc sulfate and water for injection, q.s.

25 mg per 5 mL Pharmacy Bulk Package vial: Each mL contains 5 mg of zinc present as 12.32 mg of zinc sulfate and water for injection, q.s.

All presentations do not contain preservatives.

The pH range is 2 to 4; pH may be adjusted with sulfuric acid.

1 mg/mL of Zinc Sulfate Injection contains no more than 1,500 mcg/L of aluminum and has a calculated osmolarity of 33 mOsmol/L.

3 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 96.5 mOsmol/L.

5 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 157.2 mOsmol/L.

Zinc sulfate heptahydrate, USP has a molecular weight of 287.54 g/mol and a formula of ZnSO4·7H2O.

Dosage Forms and Strengths

Zinc Sulfate Injection, USP:

  • 10 mg per10 mL (1 mg per mL) of zinc as a clear, colorless solution in a 10 mL Pharmacy Bulk Package vial.
  • 30 mg per 10 mL (3 mg per mL) of zinc as a clear, colorless solution in a 10 mL Pharmacy Bulk Package vial.
  • 25 mg per 5 mL (5 mg per mL) of zinc as a clear, colorless solution in a 5 mL Pharmacy Bulk Package vial.
How Supplied

Zinc Sulfate Injection, USP is a sterile, clear, colorless solution, essentially free from visible particles supplied as:

Product CodeUnit of SaleStrengthEach
405001 NDC 65219-401-01
Unit of 25 		10 mg per 10 mL
(1 mg per mL) 		NDC 65219-401-00
10 mL Pharmacy Bulk Package vial
405003 NDC 65219-403-03
Unit of 25 		30 mg per 10 mL
(3 mg per mL) 		NDC 65219-403-01
10 mL Pharmacy Bulk Package vial
405005 NDC 65219-405-05
Unit of 25 		25 mg per 5 mL
(5 mg per mL) 		NDC 65219-405-02
5 mL Pharmacy Bulk Package vial

The container closure is not made with natural rubber latex.

FRESENIUS KABI, Lake Zurich, IL 60047
www.fresenius-kabi.com/us
451762A
 
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