Prescription drug · ANDA
Pitavastatin (pitavastatin calcium) NDC 0480-3633
Pitavastatin calcium 4.18 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3633-98 | 00480363398 | 90 TABLET, FILM COATED in 1 BOTTLE (0480-3633-98)Marketed from Nov 2, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Teva Pharmaceuticals, Inc.
- 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 0480-3633_191b4856-1662-a7b8-e063-6394a90a2c56SPL ID 191b4856-1662-a7b8-e063-6394a90a2c56SPL set ID fac09182-dcf2-1770-e053-6394a90af50cRxCUI 861643, 861648, 861652UNII IYD54XEG3WUPC 0304803633985, 0304803631981, 0304803632988
- 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
N400480363398followed by a unit qualifier and the quantityPackage 00480-3633-98. 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 and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). 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 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 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 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 4.18 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-907 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 1.045 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3631 |