Prescription drug · ANDA
Calcitriol NDC 69452-207
Calcitriol .25 ug/1 · Capsule, Liquid filled · Oral · BIONPHARMA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-207-13 | 6945202071369452020713 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-207-13)Marketed from Jun 12, 2018 | |
| 69452-207-20 | 6945202072069452020720 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-207-20)Marketed from Jun 12, 2018 |
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
- Labeler
- BIONPHARMA INC.NDC labeler code 69452
- 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 69452-207_54eeeb25-93af-421d-e063-6294a90a2714SPL ID 54eeeb25-93af-421d-e063-6294a90a2714SPL set ID 626f23d5-31e6-41ca-a696-191a4f2bc7efRxCUI 308867, 308868UNII FXC9231JVHUPC 0369452208205, 0369452207208
- 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
N469452020713followed by a unit qualifier and the quantityPackage 69452-0207-13. 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.
About NDC 69452-207
- What is NDC 69452-207?
- 69452-207 is the product NDC for Calcitriol, Calcitriol .25 ug/1 capsule, liquid filled, listed with the FDA by BIONPHARMA INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calcitriol.
- What is the active ingredient?
- Calcitriol.
- Who is the labeler?
- BIONPHARMA INC., NDC labeler code 69452. 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 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 .25 ug/1 | Capsule, Liquid filledOral | Golden State Medical Supply, Inc. | 51407-169 |
| Calcitriol | Calcitriol .5 ug/1 | Capsule, Liquid filledOral | Golden State Medical Supply, Inc. | 51407-170 |
| Calcitriol | Calcitriol .5 ug/1 | Capsule, Liquid filledOral | BIONPHARMA INC. | 69452-208 |
| Calcitriol | Calcitriol .5 ug/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 71335-1782 |
| Calcitriol | Calcitriol .25 ug/1 | Capsule, Liquid filledOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-468 |