Product Specifications
| Specification | Details |
| Manufacturer / Brand | Fresenius Kabi USA, LLC |
| Manufacturer SKU / Item # | 63323036019 |
| NDC Number | 63323-0360-19 (Box) / 63323-0360-01 (Vial) |
| Concentration / Strength | 10% (100 mg/mL) |
| Elemental Calcium Content | 9.3 mg (0.465 mEq) elemental calcium per mL |
| Total Content per Vial | 1,000 mg Calcium Gluconate Monohydrate (93 mg / 4.65 mEq) |
| Volume per Unit | 10 mL |
| Container Type | Glass Single-Dose Vial (SDV) |
| Administration Route | Intravenous (IV) Infusion or Slow IV Injection |
| Formulation | Preservative-Free / Sterile / pH 6.0 to 8.2 |
| Storage Temperature | 20°C to 25°C (68°F to 77°F) (Controlled Room Temperature) |
| Packaging Configuration | 25 Vials per Box / Tray |
| Regulatory Category | Prescription-Only (Rx) |
| HCPCS Code |
Key Features & Clinical Applications
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Acute Hypocalcemia Restoration: Rapid-acting intravenous calcium indicated for pediatric and adult patients to quickly elevate serum calcium levels during acute, symptomatic hypocalcemia (e.g., tetany, post-thyroidectomy/parathyroidectomy support).
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Preservative-Free Formulation: Formulated without added preservatives or benzyl alcohol, ensuring full safety and compliance across sensitive neonate, pediatric, and adult patient populations.
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Cardioprotective & Tissue-Tolerant: Less caustic to peripheral vascular tissues than Calcium Chloride, making it the preferred calcium salt when central venous access is unestablished.
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Standardized 10 mL Unit Size: Convenient 1,000 mg single-dose vial size simplifies dosage calculations and rapid bedside preparation in emergency and clinical settings.
⚠️ Administration Precaution: Dilute in 5% Dextrose or Normal Saline prior to continuous or intermittent infusion. Administer via slow IV push (not exceeding 2 mL per minute) or slow infusion. Rapid intravenous administration can trigger severe hypotension, bradycardia, and cardiac arrhythmias.
⚠️ Neonatal Contraindication: Contraindicated in neonates (28 days of age or younger) receiving concurrent ceftriaxone due to the risk of fatal ceftriaxone-calcium precipitates in vital organs.
⚠️ Incompatibility Notice: Incompatible with fluids containing phosphates or carbonates—mixing will cause precipitate formation. Flush IV lines thoroughly between infusions.
