Prescription drug · ANDA
Calcitriol NDC 63629-8742
Calcitriol .5 ug/1 · Capsule, Liquid filled · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8742-1 | 63629874201 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8742-1)Marketed from Aug 20, 2021 |
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)
- Calcitriol
- Generic name (nonproprietary)
- calcitriol
- Active ingredients
- Calcitriol — .5 ug/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075765
- Marketing start
- Listing expires
- Other FDA classes
- Cholecalciferol (Chemical structure)
- Identifiers
- Product ID 63629-8742_8abfa075-cc08-4c58-a57c-7ec530ba4225SPL ID 8abfa075-cc08-4c58-a57c-7ec530ba4225SPL set ID 6c68beb7-1fed-4652-b4e1-672fde0b621dRxCUI 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
N463629874201followed by a unit qualifier and the quantityPackage 63629-8742-01. 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 is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (C cr 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 se…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075765
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 | Bryant Ranch Prepack | 63629-8741 |
| Calcitriol | Calcitriol .25 ug/1 | Capsule, Liquid filledOral | Teva Pharmaceuticals USA, Inc. | 0093-7352 |
| Calcitriol | Calcitriol .5 ug/1 | Capsule, Liquid filledOral | Teva Pharmaceuticals USA, Inc. | 0093-7353 |
| Calcitriol | Calcitriol .25 ug/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 72162-1031 |
| Calcitriol | Calcitriol .5 ug/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 71335-1594 |