Prescription drug · ANDA
Pitavastatin (pitavastatin calcium) NDC 42291-907
Pitavastatin calcium 4.18 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-907-90 | 42291090790 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-907-90)Marketed from Jan 16, 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 calcium
- Active ingredients
- Pitavastatin calcium — 4.18 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205932
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 42291-907_48843604-c6e9-1aec-e063-6294a90aea80SPL ID 48843604-c6e9-1aec-e063-6294a90aea80SPL set ID 0f11ee80-871e-4f13-e063-6394a90af19dRxCUI 861643, 861648, 861652UNII IYD54XEG3W
- 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
N442291090790followed by a unit qualifier and the quantityPackage 42291-0907-90. 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)
Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adult with primary hyperlipidemia. Adults with heterozygous familial hypercholesterolemia (HeFH). Pediatric use information is approved for Kowa Co Ltd’s LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd’s marketing exclusivity rights, this drug product is not labeled with that information. Pitavastatin is a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) Adult patients with primary hyperlipidemia. Adults with heterozygous familial hypercholesterolemia (HeFH).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205932
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 |
|---|---|---|---|---|
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 2.09 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3632 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 4.18 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3633 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 1.045 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-905 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 2.09 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-906 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 1.045 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3631 |