Prescription drug · ANDA
Pitavastatin NDC 65862-812
Pitavastatin calcium 1 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-812-05 | 6586208120565862081205 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-812-05)Marketed from Nov 2, 2023 | |
| 65862-812-90 | 6586208129065862081290 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-812-90)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
- Generic name (nonproprietary)
- pitavastatin
- Active ingredients
- Pitavastatin calcium — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206015
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-812_9a71c5a7-aaf8-4650-aba4-da6ba84d03a7SPL ID 9a71c5a7-aaf8-4650-aba4-da6ba84d03a7SPL set ID a52401eb-a822-475b-a40d-7b8acde2ae1aRxCUI 861643, 861648, 861652UNII IYD54XEG3WUPC 0365862813909, 0365862812902
- 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
N465862081205followed by a unit qualifier and the quantityPackage 65862-0812-05. 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 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.
About NDC 65862-812
- What is NDC 65862-812?
- 65862-812 is the product NDC for Pitavastatin, Pitavastatin calcium 1 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pitavastatin.
- What is the active ingredient?
- Pitavastatin calcium.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pitavastatin?
- 17 other product NDCs are listed under this name. See all Pitavastatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pitavastatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pitavastatin | Pitavastatin calcium 1 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-029 | 65162-0029-0365162-0029-0965162-0029-50 |
| Pitavastatin | Pitavastatin calcium 2 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-030 | 65162-0030-0365162-0030-0965162-0030-50 |
| Pitavastatin | Pitavastatin calcium 4 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-031 | 65162-0031-0365162-0031-0965162-0031-50 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 1.045 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-905 | 42291-0905-90 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 2.09 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-906 | 42291-0906-90 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 4.18 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-907 | 42291-0907-90 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 1.045 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3631 | 00480-3631-98 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 2.09 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3632 | 00480-3632-98 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 4.18 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3633 | 00480-3633-98 |
| Pitavastatinpitavastatin calcium | Pitavastatin calcium 1 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-6048 | 00832-6048-90 |
Other NDCs under ANDA 206015
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 | Pitavastatin calcium 2 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-813 |
| Pitavastatin | Pitavastatin calcium 4 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-814 |