Pitavastatin NDC 65162-031

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-031Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0031Add 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
65162-031-03	65162003103	30 TABLET, FILM COATED in 1 BOTTLE (65162-031-03)Marketed from Aug 21, 2024
65162-031-09	65162003109	90 TABLET, FILM COATED in 1 BOTTLE (65162-031-09)Marketed from Aug 21, 2024
65162-031-50	65162003150	500 TABLET, FILM COATED in 1 BOTTLE (65162-031-50)Marketed from Aug 21, 2024

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 — 4 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205961
Marketing start: Aug 21, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 65162-031_ab7d1d71-229c-4528-9c2d-59d268c48c25SPL ID ab7d1d71-229c-4528-9c2d-59d268c48c25SPL set ID 7fbfcc0c-9251-456d-a525-e62cfd8abd4bRxCUI 861643, 861648, 861652UNII IYD54XEG3WUPC 0365162030099, 0365162031096, 0365162029093
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

N465162003103 followed by a unit qualifier and the quantity

Package 65162-0031-03. 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 Jul 24, 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 tablets are 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 205961

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

FDA NDC Directory listings under ANDA 205961
Product	Strength	Form · route	Labeler	Product NDC
Pitavastatin	Pitavastatin calcium 1 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-029
Pitavastatin	Pitavastatin calcium 2 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-030