Prescription drug · ANDA
Calcium Chloride NDC 76329-3304
Calcium chloride 100 mg/mL · Injection · Intravenous, Intraventricular · International Medication Systems, Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76329-3304-1 | 76329330401 | 10 SYRINGE in 1 PACKAGE (76329-3304-1) / 10 mL in 1 SYRINGEMarketed from Jul 8, 2018 |
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 Chloride
- Generic name (nonproprietary)
- calcium chloride
- Active ingredients
- Calcium chloride — 100 mg/mL
- Dosage form
- Injection
- Route
- Intravenous, Intraventricular
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203477
- 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 76329-3304_fe9c2714-4299-4327-96cd-cf3ab03efcdeSPL ID fe9c2714-4299-4327-96cd-cf3ab03efcdeSPL set ID 8295039b-2559-4626-90c8-6ac7e896e41aRxCUI 828527UNII 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
N476329330401followed by a unit qualifier and the quantityPackage 76329-3304-01. 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. C alcium Chloride Injection is a form of calcium indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. (1) 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 203477
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 | InjectionIntravenous, Intraventricular | ProPharma Distribution | 84549-304 |
| Calcium Chloride | Calcium chloride 100 mg/mL | InjectionIntravenous, Intraventricular | HF Acquisition Co LLC, DBA HealthFirst | 51662-1379 |
| Calcium Chloride | Calcium chloride 100 mg/mL | InjectionIntravenous, Intraventricular | REMEDYREPACK INC. | 70518-4180 |