Paricalcitol NDC 65162-824

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-824Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0824Add 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
65162-824-03	65162082403	30 CAPSULE in 1 BOTTLE (65162-824-03)Marketed from Jan 15, 2016
65162-824-09	65162082409	90 CAPSULE in 1 BOTTLE (65162-824-09)Marketed from Jan 15, 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): Paricalcitol
Generic name (nonproprietary): paricalcitol
Active ingredients: Paricalcitol — 4 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 204327
Marketing start: Jan 15, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Ergocalciferols (Chemical structure)
Identifiers: Product ID 65162-824_35e96bd0-ee09-4adc-a04d-7dcd43466786SPL ID 35e96bd0-ee09-4adc-a04d-7dcd43466786SPL set ID cd937aab-6ed2-44ef-b91e-82738997ed10RxCUI 577315, 577317, 577324UNII 6702D36OG5UPC 0365162822090, 0365162823097, 0365162824094
Pharmacologic class: Vitamin D Analog; Vitamin D2 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

N465162082403 followed by a unit qualifier and the quantity

Package 65162-0824-03. 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 Apr 30, 2017.

Indications (excerpt from the label)

Paricalcitol capsules are a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4 (1.1) . CKD Stage 5 in patients on hemodialysis or peritoneal dialysis (1.2) . 1.1 Chronic Kidney Disease Stages 3 and 4 Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not label…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204327

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

FDA NDC Directory listings under ANDA 204327
Product	Strength	Form · route	Labeler	Product NDC
Paricalcitol	Paricalcitol 1 ug/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-822
Paricalcitol	Paricalcitol 2 ug/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-823