Prescription drug · ANDA
Fenofibrate NDC 51655-009
Fenofibrate 160 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-009-52 | 51655000952 | 30 TABLET in 1 BOTTLE, DISPENSING (51655-009-52)Marketed from May 7, 2014 |
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)
- Fenofibrate
- Generic name (nonproprietary)
- fenofibrate
- Active ingredients
- Fenofibrate — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076509
- Marketing start
- Listing expires
- Identifiers
- Product ID 51655-009_46dda39a-93fb-1900-e063-6294a90a96f4SPL ID 46dda39a-93fb-1900-e063-6294a90a96f4SPL set ID 4b4447a1-8136-4258-b2c8-c5f9c1bcec92RxCUI 349287UNII U202363UOS
- Pharmacologic class
- Peroxisome Proliferator Receptor alpha Agonist
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
N451655000952followed by a unit qualifier and the quantityPackage 51655-0009-52. 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)
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. ( 1.1 ) For treatment of adult patients with severe hypertriglyceridemia. ( 1.2 ) Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. ( 5.1 ) 1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (T…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076509
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 |
|---|---|---|---|---|
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4326 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-410 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-5511 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-5522 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-5511 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 60219-5522 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | AvPAK | 50268-313 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | AvPAK | 50268-312 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-6973 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-6974 |