Prescription drug · ANDA
pitavastatin calcium NDC 70771-1785
Pitavastatin calcium 2 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1785-9 | 70771178509 | 90 TABLET in 1 BOTTLE (70771-1785-9)Marketed from Nov 2, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- 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 70771-1785_e441676b-f28d-4506-9b0e-b8e28b1f7d1fSPL ID e441676b-f28d-4506-9b0e-b8e28b1f7d1fSPL set ID 7b1a9aa6-a7a4-4050-8a40-89ba9728555aRxCUI 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
N470771178509followed by a unit qualifier and the quantityPackage 70771-1785-09. 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 .
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 1 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-481 |
| 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 1 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1784 |
| pitavastatin calcium | Pitavastatin calcium 4 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1786 |