Prescription drug · NDA
Calcium Gluconate NDC 65219-164
Calcium gluconate monohydrate 20 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-164-50 | 65219016450 | 24 BAG in 1 CASE (65219-164-50) / 100 mL in 1 BAG (65219-164-01)Marketed from Jun 17, 2021 |
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 Gluconate
- Generic name (nonproprietary)
- calcium gluconate
- Active ingredients
- Calcium gluconate monohydrate — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208418
- 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 65219-164_3351b72a-aa15-419f-a58c-4df90573d9f9SPL ID 3351b72a-aa15-419f-a58c-4df90573d9f9SPL set ID 7f5101e0-abf9-4fcf-8986-c799e3333434RxCUI 2117608, 2117610UNII CZN0MI5R31
- 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
N465219016450followed by a unit qualifier and the quantityPackage 65219-0164-50. 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 Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Calcium Gluconate in Sodium Chloride Injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. ( 1 ) Limitations of Use: The safety of Calcium Gluconate Injection for long term use has not been established. ( 1 ) Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208418
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 Gluconate | Calcium gluconate monohydrate 20 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-162 |
| Calcium Gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9831 |
| Calcium Gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7222 |
| Calcium Gluconate | Calcium gluconate monohydrate 100 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-360 |
| Calcium Gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1312 |
| Calcium Gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-630 |
| Calcium Gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1347 |
| Calcium Gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-360 |
| Calcium Gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4178 |