Prescription drug · NDA
Zypitamag (pitavastatin magnesium) NDC 25208-202
Pitavastatin 4 mg/1 · Tablet, Film coated · Oral · Medicure International Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25208-202-09 | 25208020209 | 90 TABLET, FILM COATED in 1 BOTTLE (25208-202-09)Marketed from Mar 9, 2018 | |
| 25208-202-15 | 25208020215 | 500 TABLET, FILM COATED in 1 BOTTLE (25208-202-15)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 — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Medicure International Inc
- 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 25208-202_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
N425208020209followed by a unit qualifier and the quantityPackage 25208-0202-09. 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.
Other NDCs under NDA 208379
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zypitamagpitavastatin magnesium | Pitavastatin 2 mg/1 | Tablet, Film coatedOral | Medicure International Inc | 25208-201 |
| Zypitamagpitavastatin magnesium | Pitavastatin 2 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1117 |
| Zypitamagpitavastatin magnesium | Pitavastatin 4 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1118 |