Prescription drug · ANDA
Calcitriol (Calcitriol capsules 0.25 mcg) NDC 71610-870
Calcitriol .25 ug/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-870-30 | 7161008703071610087030 | 30 CAPSULE in 1 BOTTLE (71610-870-30)Marketed from Dec 17, 2024 |
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
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-870_29b8cf3d-3835-602b-e063-6294a90a89ceSPL ID 29b8cf3d-3835-602b-e063-6294a90a89ceSPL set ID 29b8cc1f-0491-0a95-e063-6294a90a223dRxCUI 308867UNII 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
N471610087030followed by a unit qualifier and the quantityPackage 71610-0870-30. 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.
About NDC 71610-870
- What is NDC 71610-870?
- 71610-870 is the product NDC for Calcitriol (calcitriol capsules 0.25 mcg), Calcitriol .25 ug/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calcitriol (Calcitriol Capsules 0.25 mcg).
- What is the active ingredient?
- Calcitriol.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Calcitriol?
- 39 other product NDCs are listed under this name. See all Calcitriol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calcitriol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calcitriol | Calcitriol 1 ug/mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-831 | 70954-0831-10 |
| Calcitriol | Calcitriol .25 ug/1 | CapsuleOral | EPIC PHARMA LLC | 42806-732 | 42806-0732-01 |
| Calcitriol | Calcitriol .5 ug/1 | CapsuleOral | EPIC PHARMA LLC | 42806-733 | 42806-0733-01 |
| Calcitriol | Calcitriol .25 ug/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 72162-1031 | 72162-1031-01 |
| Calcitriol | Calcitriol 1 ug/mL | SolutionOral | Patrin Pharma, Inc | 39328-042 | 39328-0042-15 |
| Calcitriol | Calcitriol 1 ug/mL | InjectionIntravenous | FOSUN PHARMA USA INC | 72266-251 | 72266-0251-10 |
| Calcitriol | Calcitriol .25 ug/1 | Capsule, Liquid filledOral | Sun Pharmaceutical Industries, Inc. | 62756-967 | 62756-0967-1862756-0967-8362756-0967-88 |
| Calcitriol | Calcitriol .5 ug/1 | Capsule, Liquid filledOral | Sun Pharmaceutical Industries, Inc. | 62756-968 | 62756-0968-1862756-0968-8362756-0968-88 |
| Calcitriol | Calcitriol 1 ug/mL | InjectionIntravenous | Gland Pharma Limited | 68083-316 | 68083-0316-10 |
| Calcitriolcalcitriol capsules 0.25 mcg | Calcitriol .25 ug/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-8186 | 55154-8186-00 |
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 0.5 mcg | Calcitriol .5 ug/1 | CapsuleOral | Strides Pharma Science Limited | 64380-724 |
| Calcitriolcalcitriol capsules 0.25 mcg | Calcitriol .25 ug/1 | CapsuleOral | Strides Pharma Science Limited | 64380-723 |
| Calcitriolcalcitriol capsules 0.25 mcg | Calcitriol .25 ug/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-8186 |
| 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 |
| 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 |