Prescription drug · ANDA
Calcitriol NDC 51407-169
Calcitriol .25 ug/1 · Capsule, Liquid filled · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-169-01 | 51407016901 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51407-169-01)Marketed from Jan 3, 2019 |
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 — .25 ug/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091174
- Marketing start
- Listing expires
- Other FDA classes
- Cholecalciferol (Chemical structure)
- Identifiers
- Product ID 51407-169_55f7b058-2d1d-31e2-e063-6294a90adcd2SPL ID 55f7b058-2d1d-31e2-e063-6294a90adcd2SPL set ID 8465337c-86ca-ea9d-e053-2991aa0ab167RxCUI 308867, 308868UNII FXC9231JVH
- 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
N451407016901followed by a unit qualifier and the quantityPackage 51407-0169-01. 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)
INDICATIONS AND USAGE Predialysis Patients Calcitriol capsules are 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 capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules administration enhances ca…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091174
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 .25 ug/1 | Capsule, Liquid filledOral | A-S Medication Solutions | 50090-6711 |
| Calcitriol | Calcitriol .5 ug/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 71335-1782 |
| Calcitriol | Calcitriol .5 ug/1 | Capsule, Liquid filledOral | Golden State Medical Supply, Inc. | 51407-170 |
| Calcitriol | Calcitriol .25 ug/1 | Capsule, Liquid filledOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-468 |
| Calcitriol | Calcitriol .25 ug/1 | Capsule, Liquid filledOral | BIONPHARMA INC. | 69452-207 |
| Calcitriol | Calcitriol .5 ug/1 | Capsule, Liquid filledOral | BIONPHARMA INC. | 69452-208 |