Prescription drug · ANDA
Fenofibrate NDC 51079-599
Fenofibrate 48 mg/1 · Tablet, Film coated · Oral · Mylan Institutional Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51079-599-20 | 51079059920 | 100 BLISTER PACK in 1 CARTON (51079-599-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-599-01)Marketed from Jun 10, 2013 |
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 — 48 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Institutional Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202856
- Marketing start
- Listing expires
- Identifiers
- Product ID 51079-599_3ac22e61-98d2-068c-e063-6394a90ae338SPL ID 3ac22e61-98d2-068c-e063-6394a90ae338SPL set ID 5a90e0a4-7892-462f-9776-037d23a93b10RxCUI 477560, 477562UNII 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
N451079059920followed by a unit qualifier and the quantityPackage 51079-0599-20. 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 tablets are 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 choles…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202856
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 145 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-608 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2016 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-3065 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-3066 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-040 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7242 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-039 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6934 |