Pitavastatin Calcium (pitavastatin) NDC 0378-5055

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-5055Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-5055Add 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
0378-5055-77	00378505577	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5055-77)Marketed from Nov 2, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Calcium
Generic name (nonproprietary): pitavastatin
Active ingredients: Pitavastatin calcium — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206070
Marketing start: Nov 2, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 0378-5055_44bb6612-917c-4457-952a-5751ea607867SPL ID 44bb6612-917c-4457-952a-5751ea607867SPL set ID 26b5e5e8-45cd-4a98-9af4-2d04c1130881RxCUI 861643, 861648, 861652UNII IYD54XEG3WUPC 0303785057772, 0303785056775, 0303785055778
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

N400378505577 followed by a unit qualifier and the quantity

Package 00378-5055-77. 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 Aug 15, 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 206070

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

FDA NDC Directory listings under ANDA 206070
Product	Strength	Form · route	Labeler	Product NDC
Pitavastatin Calciumpitavastatin	Pitavastatin calcium 2 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5056
Pitavastatin Calciumpitavastatin	Pitavastatin calcium 4 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5057