Prescription drug · ANDA
Pitavastatin (pitavastatin calcium) NDC 0832-6050
Pitavastatin calcium 4 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-6050-90 | 00832605090 | 90 TABLET in 1 BOTTLE (0832-6050-90)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 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205955
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 0832-6050_53c2bd9a-c6ee-8b8c-e063-6294a90a5a95SPL ID 53c2bd9a-c6ee-8b8c-e063-6294a90a5a95SPL set ID 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924RxCUI 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
N400832605090followed by a unit qualifier and the quantityPackage 00832-6050-90. 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: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets 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 ANDA 205955
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 1 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-6048 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 2 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-6049 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 2 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-957 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 1 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-956 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 4 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-958 |