Prescription drug · ANDA
Fenofibrate NDC 42291-045
Fenofibrate 145 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-045-90 | 42291004590 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-045-90)Marketed from Jan 4, 2024 |
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 — 145 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204598
- Marketing start
- Listing expires
- Identifiers
- Product ID 42291-045_484c0370-9350-0c79-e063-6394a90afce7SPL ID 484c0370-9350-0c79-e063-6394a90afce7SPL set ID 0e240290-f11b-8cc4-e063-6294a90a74f0RxCUI 477560UNII 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
N442291004590followed by a unit qualifier and the quantityPackage 42291-0045-90. 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 tablets are peroxisome proliferator receptor alpha (PPARα) activator 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 ). Important 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 c…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204598
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 | A-S Medication Solutions | 50090-3044 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3056 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8106 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2654 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2688 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-595 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-596 |