Prescription drug · ANDA
Fenofibrate NDC 59651-575
Fenofibrate 54 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-575-90 | 59651057590 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-575-90)Marketed from Sep 27, 2022 |
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 — 54 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216798
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-575_728e5bad-086b-492f-9ecc-ad9562e5e25eSPL ID 728e5bad-086b-492f-9ecc-ad9562e5e25eSPL set ID a7cfa38f-b4db-40d3-8821-3f7c85e2727eRxCUI 349287, 351133UNII 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
N459651057590followed by a unit qualifier and the quantityPackage 59651-0575-90. 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 (To…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216798
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 54 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4721 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8861 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7208 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7209 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-576 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3542 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7572 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3086 |