Prescription drug · ANDA
calcium chloride NDC 76483-108
Calcium chloride 100 mg/mL · Injection, Solution · Intravenous · SQUARE PHARMACEUTICALS PLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76483-108-02 | 76483010802 | 10 VIAL in 1 BOX (76483-108-02) / 10 mL in 1 VIAL (76483-108-01)Marketed from Jan 15, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- calcium chloride
- Generic name (nonproprietary)
- calcium chloride
- Active ingredients
- Calcium chloride — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- SQUARE PHARMACEUTICALS PLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217463
- Marketing start
- Listing expires
- Other FDA classes
- Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 76483-108_e0f2dac8-19e2-4090-b520-c81b971c8598SPL ID e0f2dac8-19e2-4090-b520-c81b971c8598SPL set ID 753c3973-6522-4d33-811b-b63a4e8cc585RxCUI 828525UNII M4I0D6VV5M
- Pharmacologic class
- Blood Coagulation Factor; Phosphate Binder
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N476483010802followed by a unit qualifier and the quantityPackage 76483-0108-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use The safety and effectiveness of calcium chloride injection for long-term use has not been established. Calcium chloride injection is a form of calcium indicated for the treatment of adult and pediatric and patients with acute symptomatic hypocalcemia. Limitations of Use: The safety and effectiveness of calcium chloride injection for long-term use has not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217463
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| calcium chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | PAI Holdings, LLC dba PAI Pharma | 0121-1099 |
| calcium chloride | Calcium chloride 100 mg/mL | Injection, SolutionIntravenous | Eskayef Pharmaceuticals Limited | 72658-1879 |