What is NDC 71610-521?

71610-521 is the product NDC for Calcitriol, 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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Calcitriol NDC 71610-521 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-521Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0521Add 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	Copy
71610-521-09	7161005210971610052109	9000 CAPSULE in 1 BOTTLE, PLASTIC (71610-521-09)Marketed from Feb 4, 2021

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
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 076917
Marketing start: Mar 27, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Cholecalciferol (Chemical structure)
Identifiers: Product ID 71610-521_73591ad3-4894-41a5-968a-1955b2a52105SPL ID 73591ad3-4894-41a5-968a-1955b2a52105SPL set ID adb1b2d5-33a7-4442-9074-cc1a89966528RxCUI 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

N471610052109 followed by a unit qualifier and the quantity

Package 71610-0521-09. 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 Mar 14, 2021.

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 (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 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 seru…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-521

What is NDC 71610-521?: 71610-521 is the product NDC for Calcitriol, 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.
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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Calcitriol NDCs
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

All 40 Calcitriol NDCs

Other NDCs under ANDA 076917

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

FDA NDC Directory listings under ANDA 076917
Product	Strength	Form · route	Labeler	Product NDC
Calcitriol	Calcitriol .25 ug/1	CapsuleOral	Hikma Pharmaceuticals USA Inc.	0054-0007
Calcitriol	Calcitriol .25 ug/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-058