Calcitriol NDC 65162-576

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-576Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0576Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
65162-576-03	65162057603	30 CAPSULE in 1 BOTTLE (65162-576-03)Marketed from Jun 18, 2017
65162-576-10	65162057610	100 CAPSULE in 1 BOTTLE (65162-576-10)Marketed from Jun 18, 2017
65162-576-25	65162057625	250 CAPSULE in 1 BOTTLE (65162-576-25)Marketed from Jun 18, 2017

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 — .5 ug/1
Dosage form: Capsule
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203289
Marketing start: Jun 18, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cholecalciferol (Chemical structure)
Identifiers: Product ID 65162-576_ef9469b2-7a07-48f6-b7be-8a8ae57f08e4SPL ID ef9469b2-7a07-48f6-b7be-8a8ae57f08e4SPL set ID b1fef137-63c5-4662-8cd9-b9e8b12bacb6RxCUI 308867, 308868UNII FXC9231JVHUPC 0365162519037, 0365162576030
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

N465162057603 followed by a unit qualifier and the quantity

Package 65162-0576-03. 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 Oct 23, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Predialysis Patients Calcitriol capsules re 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 calc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203289

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203289
Product	Strength	Form · route	Labeler	Product NDC
Calcitriol	Calcitriol .25 ug/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-519