Prescription drug · ANDA
Calcium Gluconate NDC 0264-5600
Calcium gluconate monohydrate 98 mg/mL · Injection, Solution · Intravenous · B. Braun Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0264-5600-52 | 0026456005200264560052 | 24 CONTAINER in 1 CASE (0264-5600-52) / 100 mL in 1 CONTAINERMarketed from Nov 2, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 98 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- B. Braun Medical Inc.NDC labeler code 0264
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216541
- 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 0264-5600_c39effaa-a9b8-4430-a42a-c642b76550dfSPL ID c39effaa-a9b8-4430-a42a-c642b76550dfSPL set ID af362bcb-7010-4eb5-b8c4-42aa3b0cdcdeUNII 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
N400264560052followed by a unit qualifier and the quantityPackage 00264-5600-52. 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.
About NDC 0264-5600
- What is NDC 0264-5600?
- 0264-5600 is the product NDC for Calcium Gluconate, Calcium gluconate monohydrate 98 mg/mL injection, solution, listed with the FDA by B. Braun Medical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calcium Gluconate.
- What is the active ingredient?
- Calcium gluconate monohydrate.
- Who is the labeler?
- B. Braun Medical Inc., NDC labeler code 0264. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Calcium Gluconate?
- 29 other product NDCs are listed under this name. See all Calcium Gluconate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calcium Gluconate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calcium Gluconate | Calcium gluconate monohydrate 100 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-170 | 65145-0170-25 |
| Calcium Gluconate | Calcium gluconate monohydrate 100 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-171 | 65145-0171-25 |
| Calcium Gluconate | Calcium gluconate monohydrate 100 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-172 | 65145-0172-20 |
| Calcium Gluconate | Calcium gluconate monohydrate 100 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-789 | 68462-0789-25 |
| Calcium Gluconate | Calcium gluconate monohydrate 100 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-790 | 68462-0790-25 |
| Calcium Gluconate | Calcium gluconate monohydrate 100 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-791 | 68462-0791-20 |
| calcium gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1672 | 80830-1672-04 |
| Calcium Gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9764 | 00404-9764-10 |
| calcium gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4355 | 70518-4355-00 |
| Calcium Gluconate | Calcium gluconate monohydrate 98 mg/mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4178 | 70518-4178-00 |