Pitavastatin NDC 65862-812

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-812Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0812Add 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
65862-812-05	65862081205	500 TABLET, FILM COATED in 1 BOTTLE (65862-812-05)Marketed from Nov 2, 2023
65862-812-90	65862081290	90 TABLET, FILM COATED in 1 BOTTLE (65862-812-90)Marketed from Nov 2, 2023

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): Pitavastatin
Generic name (nonproprietary): pitavastatin
Active ingredients: Pitavastatin calcium — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206015
Marketing start: Nov 2, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 65862-812_9a71c5a7-aaf8-4650-aba4-da6ba84d03a7SPL ID 9a71c5a7-aaf8-4650-aba4-da6ba84d03a7SPL set ID a52401eb-a822-475b-a40d-7b8acde2ae1aRxCUI 861643, 861648, 861652UNII IYD54XEG3WUPC 0365862813909, 0365862812902
Pharmacologic class: HMG-CoA Reductase Inhibitor

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

N465862081205 followed by a unit qualifier and the quantity

Package 65862-0812-05. 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 12, 2024.

Indications (excerpt from the label)

Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin is a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206015

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

FDA NDC Directory listings under ANDA 206015
Product	Strength	Form · route	Labeler	Product NDC
Pitavastatin	Pitavastatin calcium 4 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-814
Pitavastatin	Pitavastatin calcium 2 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-813