Prescription drug · ANDA
Calcium Gluconate NDC 80830-2363
Calcium gluconate monohydrate 20 mg/mL · Injection, Solution · Intravenous · Amneal Pharmaceuticals Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80830-2363-2 | 80830236302 | 12 POUCH in 1 CARTON (80830-2363-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Nov 8, 2023 | |
| 80830-2363-9 | 80830236309 | 24 POUCH in 1 CARTON (80830-2363-9) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Sep 8, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217174
- 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 80830-2363_2bd614b6-02ce-49e3-86e2-dfaec7a13e04SPL ID 2bd614b6-02ce-49e3-86e2-dfaec7a13e04SPL set ID 8ee79b4c-21d3-4742-ae37-e2f562917706RxCUI 2117608, 2117610UNII CZN0MI5R31UPC 0380830236290
- 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
N480830236302followed by a unit qualifier and the quantityPackage 80830-2363-02. 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 gluconate in sodium chloride injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of calcium gluconate injection for long term use has not been established. 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 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217174
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 | Amneal Pharmaceuticals Private Limited | 80830-2362 |