Prescription drug · NDA
Livalo (pitavastatin calcium) NDC 66869-404
Pitavastatin calcium 4.18 mg/1 · Tablet, Film coated · Oral · Kowa Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66869-404-90 | 66869040490 | 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-404-90)Marketed from May 16, 2019 |
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)
- Livalo
- Generic name (nonproprietary)
- pitavastatin calcium
- Active ingredients
- Pitavastatin calcium — 4.18 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022363
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 66869-404_aacce141-185f-4d20-adb1-6cca3a9c87c4SPL ID aacce141-185f-4d20-adb1-6cca3a9c87c4SPL set ID 44dcbf97-99ec-427c-ba50-207e0069d6d2RxCUI 861643, 861646, 861648, 861650, 861652, 861654UNII IYD54XEG3WUPC 0366869204905, 0366869404909, 0366869104908
- 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
N466869040490followed by a unit qualifier and the quantityPackage 66869-0404-90. 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)
LIVALO is 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). LIVALO 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.
Other NDCs under NDA 022363
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 |
|---|---|---|---|---|
| Livalopitavastatin calcium | Pitavastatin calcium 1.045 mg/1 | Tablet, Film coatedOral | Kowa Pharmaceuticals America, Inc. | 66869-104 |
| Livalopitavastatin calcium | Pitavastatin calcium 2.09 mg/1 | Tablet, Film coatedOral | Kowa Pharmaceuticals America, Inc. | 66869-204 |