Prescription drug · ANDA
Pitavastatin Calcium (Pitavastatin) NDC 0378-5056
Pitavastatin calcium 2 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-5056-77 | 0037850567700378505677 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5056-77)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 Calcium
- Generic name (nonproprietary)
- pitavastatin
- Active ingredients
- Pitavastatin calcium — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206070
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 0378-5056_44bb6612-917c-4457-952a-5751ea607867SPL ID 44bb6612-917c-4457-952a-5751ea607867SPL set ID 26b5e5e8-45cd-4a98-9af4-2d04c1130881RxCUI 861643, 861648, 861652UNII IYD54XEG3WUPC 0303785057772, 0303785056775, 0303785055778
- 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
N400378505677followed by a unit qualifier and the quantityPackage 00378-5056-77. 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.
About NDC 0378-5056
- What is NDC 0378-5056?
- 0378-5056 is the product NDC for Pitavastatin Calcium (pitavastatin), Pitavastatin calcium 2 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pitavastatin Calcium (Pitavastatin).
- What is the active ingredient?
- Pitavastatin calcium.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 Calcium?
- 16 other product NDCs are listed under this name. See all Pitavastatin Calcium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pitavastatin Calcium 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 calcium | Pitavastatin calcium 1 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-291 | 72865-0291-90 |
| pitavastatin calcium | Pitavastatin calcium 2 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-292 | 72865-0292-90 |
| pitavastatin calcium | Pitavastatin calcium 4 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-293 | 72865-0293-90 |
| pitavastatin calcium | Pitavastatin calcium 2.09 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-479 | 72603-0479-01 |
| pitavastatin calcium | Pitavastatin calcium 4.18 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-480 | 72603-0480-01 |
| pitavastatin calcium | Pitavastatin calcium 1.045 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-875 | 31722-0875-90 |
| pitavastatin calcium | Pitavastatin calcium 2.09 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-876 | 31722-0876-90 |
| pitavastatin calcium | Pitavastatin calcium 4.18 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-877 | 31722-0877-90 |
| Pitavastatin Calciumpitavastatin | Pitavastatin calcium 1 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-5055 | 00378-5055-77 |
| Pitavastatin Calciumpitavastatin | Pitavastatin calcium 4 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-5057 | 00378-5057-77 |
Other NDCs under ANDA 206070
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 Calciumpitavastatin | Pitavastatin calcium 1 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-5055 |
| Pitavastatin Calciumpitavastatin | Pitavastatin calcium 4 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-5057 |