VIADOX Solution for injection Ref.[50503] Active ingredients: Dexamethasone

Source: FDA, National Drug Code (US)  Revision Year: 2022 

Product description

Dexamethasone sodium phosphate injection, USP is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly.

Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3, 20-dione disodium salt.

The molecular formula is: C22H28FNa2O8P and the structural formula is:

Dexamethasone Sodium Phosphate Injection is a sterile solution of dexamethasone sodium phosphate for intravenous and intramuscular use. The 4 mg/mL strength may also be used for intra-articular, intralesional and soft tissue administration.

Each mL of Dexamethasone Sodium Phosphate Injection 4 mg/mL contains dexamethasone sodium phosphate, equivalent to 4 mg dexamethasone phosphate or 3.33 mg dexamethasone. Inactive ingredients per mL: 1 mg sodium sulfite anhydrous, 19.4 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol (preservative) in Water for Injection.

Each mL of Dexamethasone Sodium Phosphate Injection 10 mg/mL contains dexamethasone sodium phosphate, equivalent to 10 mg dexamethasone phosphate or 8.33 mg dexamethasone. Inactive ingredients per mL: 1.5 mg sodium sulfite anhydrous, 16.5 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol (preservative) in Water for Injection.

The pH of both concentrations is 7.0-8.5; sodium hydroxide and/or citric acid used, if needed, for pH adjustment. Sealed under nitrogen.

How Supplied

Dexamethasone Sodium Phosphate Injection, USP is available in the following package:

10 mg/mL – 1 mL vial

Contents (NDC 70529-045-01):

1 – 1mL Dexamethasone Sodium Phosphate (10mg/mL)
1 – 3cc Syringe w/ 18-22 Gauge 1-1 ½ in Needle (Draw)
1 – 22 Gauge 3 ½ in Needle (Administer)
1 – 23 Gauge 3 ½ in Needle (Administer)
1 – 3x3 Gauze Sponge Sterile Square
1 – Bandage 1x3 in

Contents (NDC 70529-045-02):

2 – 1mL Dexamethasone Sodium Phosphate (10mg/mL)
1 – 3cc Syringe w/ 18-22 Gauge 1-1 ½ in Needle (Draw)
1 – 22 Gauge 3 ½ in Needle (Administer)
1 – 23 Gauge 3 ½ in Needle (Administer)
1 – 3x3 Gauze Sponge Sterile Square
1 – Bandage 1x3 in

Contents (NDC 70529-045-05):

5 – 1mL Dexamethasone Sodium Phosphate (10mg/mL)
1 – 3cc Syringe w/ 18-22 Gauge 1-1 ½ in Needle (Draw)
1 – 22 Gauge 3 ½ in Needle (Administer)
1 – 23 Gauge 3 ½ in Needle (Administer)
1 – 3x3 Gauze Sponge Sterile Square
1 – Bandage 1x3 in

Assembled and Distributed by IT3 Medical, LLC, 190 E Stacy Road; STE 306-298 Allen, TX 75002-8734

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VIADOX United States

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