Product Specifications
| Specification | Details |
| Manufacturer / Brand | Amneal Biosciences LLC / Amneal Pharmaceuticals |
| Manufacturer SKU / Item # | 80830167302 |
| NDC Number | 80830-1673-2 (Carton/Tray) / 80830-1673-1 (Vial) |
| Concentration / Strength | 10% (100 mg/mL) |
| Elemental Calcium Content | 9.3 mg (0.465 mEq) elemental calcium per mL |
| Total Content per Vial | 5,000 mg Calcium Gluconate Monohydrate (465 mg / 23.25 mEq) |
| Volume per Unit | 50 mL |
| Container Type | Plastic Single-Dose Vial (SDV) |
| Administration Route | Intravenous (IV) Infusion or Slow IV Injection |
| Formulation | Preservative-Free / Sterile / Clear Solution |
| Storage Temperature | 20°C to 25°C (68°F to 77°F) (Controlled Room Temperature) |
| Packaging Configuration | 10 Vials per Carton / 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 severe, symptomatic hypocalcemia.
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Cardioprotective & Antidotal Support: Serves as a critical cardiac membrane stabilizer during severe hyperkalemia and acts as a direct physiological antagonist in hypermagnesemia toxicity.
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Preservative-Free Solution: Formulated without added preservatives or benzyl alcohol, ensuring compliance across sensitive adult, pediatric, and neonatal populations.
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High-Volume 50 mL Package: Bundled in a 25-vial carton of 50 mL vials (5,000 mg per unit), ideal for hospital central pharmacy admixtures, ICU stocking, and emergency response carts.
⚠️ Administration Precaution: Dilute in 5% Dextrose or Normal Saline prior to continuous or intermittent infusion. Administer via slow IV push (not exceeding 200 mg/min in adults or 100 mg/min in pediatrics) or slow infusion. Rapid IV administration can trigger severe hypotension, bradycardia, and cardiac arrhythmias.
⚠️ Extravasation & Necrosis Hazard: Avoid extravasation. Extravasation can lead to calcinosis cutis, severe local soft tissue inflammation, and tissue necrosis. Ensure proper placement of the IV line before starting infusion.
⚠️ Incompatibility Notice: Incompatible with fluids containing phosphates or carbonates—mixing will cause precipitate formation. Contraindicated in neonates receiving concurrent ceftriaxone due to risk of fatal calcium-ceftriaxone precipitates.
