Prescription drug · ANDA
pitavastatin calcium NDC 72603-479
Pitavastatin calcium 2.09 mg/1 · Tablet, Film coated · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-479-01 | 72603047901 | 90 TABLET, FILM COATED in 1 BOTTLE (72603-479-01)Marketed from Dec 1, 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 calcium
- Generic name (nonproprietary)
- pitavastatin calcium
- Active ingredients
- Pitavastatin calcium — 2.09 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205977
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 72603-479_27e1ba97-23bf-fc12-e063-6394a90a1699SPL ID 27e1ba97-23bf-fc12-e063-6394a90a1699SPL set ID 98e3f1df-5b38-4169-a340-adb145eac459RxCUI 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
N472603047901followed by a unit qualifier and the quantityPackage 72603-0479-01. 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: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets are 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 ANDA 205977
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 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-292 |
| pitavastatin calcium | Pitavastatin calcium 4 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-293 |
| pitavastatin calcium | Pitavastatin calcium 1 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-291 |
| pitavastatin calcium | Pitavastatin calcium 1.045 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-875 |
| pitavastatin calcium | Pitavastatin calcium 2.09 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-876 |
| pitavastatin calcium | Pitavastatin calcium 4.18 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-877 |
| pitavastatin calcium | Pitavastatin calcium 4.18 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-480 |