Prescription drug · ANDA
Calcitriol (calcitriol capsules 0.25 mcg) NDC 64380-723
Calcitriol .25 ug/1 · Capsule · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-723-04 | 64380072304 | 30 CAPSULE in 1 CONTAINER (64380-723-04)Marketed from Dec 14, 2016 | |
| 64380-723-06 | 64380072306 | 100 CAPSULE in 1 CONTAINER (64380-723-06)Marketed from Dec 10, 2016 |
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 capsules 0.25 mcg
- Active ingredients
- Calcitriol — .25 ug/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091356
- Marketing start
- Listing expires
- Other FDA classes
- Cholecalciferol (Chemical structure)
- Identifiers
- Product ID 64380-723_54ebce69-e2e7-a547-e063-6294a90a8b80SPL ID 54ebce69-e2e7-a547-e063-6294a90a8b80SPL set ID bebefb2a-7365-48e2-9681-83ed4b41e26eRxCUI 308867, 308868UNII FXC9231JVHUPC 0364380723042, 0364380723066, 0364380724063
- 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
N464380072304followed by a unit qualifier and the quantityPackage 64380-0723-04. 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 capsule 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 capsule 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 absorpt…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091356
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 |
|---|---|---|---|---|
| Calcitriolcalcitriol capsules 0.25 mcg | Calcitriol .25 ug/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-8186 |
| Calcitriol | Calcitriol .25 ug/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-662 |
| Calcitriol | Calcitriol .5 ug/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-663 |
| Calcitriolcalcitriol capsules 0.5 mcg | Calcitriol .5 ug/1 | CapsuleOral | Strides Pharma Science Limited | 64380-724 |
| Calcitriolcalcitriol capsules 0.25 mcg | Calcitriol .25 ug/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-870 |
| Calcitriol | Calcitriol .25 ug/1 | CapsuleOral | A-S Medication Solutions | 50090-7470 |
| Calcitriol | Calcitriol .25 ug/1 | CapsuleOral | Chartwell RX, LLC | 62135-610 |
| Calcitriol | Calcitriol .5 ug/1 | CapsuleOral | Chartwell RX, LLC | 62135-611 |
| Calcitriolcalcitriol capsules 0.25 mcg | Calcitriol .25 ug/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7323 |
| Calcitriolcalcitriol capsules 0.25 mcg | Calcitriol .25 ug/1 | CapsuleOral | American Health Packaging | 60687-345 |