Prescription drug · ANDA
Calcitriol NDC 39328-042
Calcitriol 1 ug/mL · Solution · Oral · Patrin Pharma, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39328-042-15 | 39328004215 | 1 BOTTLE, GLASS in 1 CARTON (39328-042-15) / 15 mL in 1 BOTTLE, GLASSMarketed from Aug 14, 2023 |
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)
- Calcitriol
- Generic name (nonproprietary)
- calcitriol
- Active ingredients
- Calcitriol — 1 ug/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Patrin Pharma, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203973
- Marketing start
- Listing expires
- Other FDA classes
- Cholecalciferol (Chemical structure)
- Identifiers
- Product ID 39328-042_6590e5b0-9097-45ca-bc73-a3dededb6901SPL ID 6590e5b0-9097-45ca-bc73-a3dededb6901SPL set ID c5c37779-0c26-438f-b1ca-61cf9915d233RxCUI 313932UNII FXC9231JVHUPC 0339328042158
- Pharmacologic class
- Vitamin D3 Analog
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N439328004215followed by a unit qualifier and the quantityPackage 39328-0042-15. 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)
INDICATIONS AND USAGE Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Calcitriol administration enhances calcium absorption, reduces ser…
Excerpt only. Read the full label for complete information.