Prescription drug · ANDA
Calcitriol NDC 72266-251
Calcitriol 1 ug/mL · Injection · Intravenous · FOSUN PHARMA USA INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72266-251-10 | 72266025110 | 10 VIAL in 1 CARTON (72266-251-10) / 1 mL in 1 VIAL (72266-251-01)Marketed from Jun 20, 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
- Injection
- Route
- Intravenous
- Labeler
- FOSUN PHARMA USA INC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211030
- Marketing start
- Listing expires
- Other FDA classes
- Cholecalciferol (Chemical structure)
- Identifiers
- Product ID 72266-251_177ba166-3f8f-49b1-e063-6394a90a0656SPL ID 177ba166-3f8f-49b1-e063-6394a90a0656SPL set ID fe7ea4da-bda0-bb00-e053-6394a90a94e7RxCUI 308869UNII FXC9231JVHUPC 0372266251107
- 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 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
N472266025110followed by a unit qualifier and the quantityPackage 72266-0251-10. 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 Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211030
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 |
|---|---|---|---|---|
| Calcitriol | Calcitriol 1 ug/mL | InjectionIntravenous | Gland Pharma Limited | 68083-316 |