Prescription drug · ANDA
calcium gluconate NDC 80830-1674
Calcium gluconate monohydrate 98 mg/mL · Injection, Solution · Intravenous · Amneal Pharmaceuticals Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80830-1674-2 | 80830167402 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-1674-2) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-1674-8)Marketed from May 13, 2024 | |
| 80830-1674-5 | 80830167405 | 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-1674-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-1674-8)Marketed from May 13, 2024 |
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 — 98 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216611
- 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 80830-1674_0602d492-1b9d-4475-8d2b-3cfc5a636793SPL ID 0602d492-1b9d-4475-8d2b-3cfc5a636793SPL set ID 13d7cfc9-ff7a-437e-8c21-d9709ac07d48RxCUI 197435, 1668248, 1668250UNII CZN0MI5R31UPC 0380830167310, 0380830167211, 0380830167488, 0380830167358
- 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
N480830167402followed by a unit qualifier and the quantityPackage 80830-1674-02. 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 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 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 216611
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 98 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1673 |
| calcium gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1672 |
| calcium gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1672 |
| calcium gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1673 |