Prescription drug · ANDA
pitavastatin calcium NDC 68382-481
Pitavastatin calcium 1 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-481-16 | 68382048116 | 90 TABLET in 1 BOTTLE (68382-481-16)Marketed from Nov 2, 2023 |
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 calcium
- Generic name (nonproprietary)
- pitavastatin calcium
- Active ingredients
- Pitavastatin calcium — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206047
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68382-481_f34ff300-0613-4b94-9fcf-475d6494ea7eSPL ID f34ff300-0613-4b94-9fcf-475d6494ea7eSPL set ID c35e747e-10ac-4a76-bce6-187618fc64f9RxCUI 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
N468382048116followed by a unit qualifier and the quantityPackage 68382-0481-16. 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 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). Pitavastatin tablets are 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 ANDA 206047
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 |
|---|---|---|---|---|
| pitavastatin calcium | Pitavastatin calcium 2 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-482 |
| pitavastatin calcium | Pitavastatin calcium 4 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-483 |
| pitavastatin calcium | Pitavastatin calcium 2 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1785 |
| pitavastatin calcium | Pitavastatin calcium 1 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1784 |
| pitavastatin calcium | Pitavastatin calcium 4 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1786 |