NDC codes

FDA NDC Directory
Product NDC (as listed)25208-201Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25208-0201Add 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 NDC11-digit (billing)PackageCopy
25208-201-092520802010990 TABLET, FILM COATED in 1 BOTTLE (25208-201-09)Marketed from Mar 9, 2018
25208-201-1525208020115500 TABLET, FILM COATED in 1 BOTTLE (25208-201-15)Marketed from Mar 9, 2018

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)
Zypitamag
Generic name (nonproprietary)
pitavastatin magnesium
Active ingredients
Pitavastatin — 2 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 208379
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 25208-201_d39ef44a-4e4d-459d-86bd-79394202e3ecSPL ID d39ef44a-4e4d-459d-86bd-79394202e3ecSPL set ID c8c50e03-5cb8-43f4-bdef-8edd12f1945fRxCUI 2001262, 2001264, 2001266, 2001268UNII M5681Q5F9PUPC 0325208202156, 0325208201159
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

N425208020109 followed by a unit qualifier and the quantity

Package 25208-0201-09. 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 .

Indications (excerpt from the label)

ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information. ZYPITAMAG is a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208379

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

FDA NDC Directory listings under NDA 208379
ProductStrengthForm · routeLabelerProduct NDC
Zypitamagpitavastatin magnesiumPitavastatin 4 mg/1Tablet, Film coatedOralMedicure International Inc25208-202
Zypitamagpitavastatin magnesiumPitavastatin 2 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1117
Zypitamagpitavastatin magnesiumPitavastatin 4 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1118

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Zypitamag (pitavastatin magnesium) NDC 25208-201 | Med-Code