Neut
FDA Label NDC 0409-6609

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hospira, Inc. for the product Neut (NDC 0409-6609). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, general surgery tray - primary label, neut sodium bicarbonate, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Neut (4% sodium bicarbonate additive solution) is a sterile, nonpyrogenic solution of sodium bicarbonate in water for injection. It is administered by the intravenous route only after addition as a neutralizing agent to an acidic large volume parenteral solution.  Each 5 mL contains sodium bicarbonate 0.2 g (2.4 mEq each of Na+ and HCO3-); edetate disodium, anhydrous 10 mg added as a stabilizer.  Total sodium (Na+) content of each 5 mL is 56.1 mg (11.2 mg/mL).

The solutions contain no bacteriostat, antimicrobial agent or added buffer; pH 8.0 (7.0 to 8.5).

Sodium Bicarbonate, USP is chemically designated as NaHCO3, a white crystalline powder soluble in water.

General Surgery Tray - Primary Label

Ns-gsurgery-sb.jpg (Ns Gsurgery Sb)

Ns-gsurgery-sb.jpg (Ns Gsurgery Sb)

Neut Sodium Bicarbonate

Neut-4-pct-sodium-bicarbonate-additive-solution-1-figure-1-jrl-0672.jpg (Neut 4 Pct Sodium Bicarbonate Additive Solution 1 Figure 1 Jrl 0672)

Neut-4-pct-sodium-bicarbonate-additive-solution-1-figure-1-jrl-0672.jpg (Neut 4 Pct Sodium Bicarbonate Additive Solution 1 Figure 1 Jrl 0672)

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