Prescription drug · ANDA
Fenofibrate NDC 35561-249
Fenofibrate 48 mg/1 · Tablet, Film coated · Oral · Bostal LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35561-249-03 | 35561024903 | 500 TABLET, FILM COATED in 1 BOTTLE (35561-249-03)Marketed from Aug 7, 2025 | |
| 35561-249-10 | 35561024910 | 30 TABLET, FILM COATED in 1 BOTTLE (35561-249-10)Marketed from Jan 1, 2021 | |
| 35561-249-11 | 35561024911 | 90 TABLET, FILM COATED in 1 BOTTLE (35561-249-11)Marketed from Aug 15, 2025 | |
| 35561-249-13 | 35561024913 | 500 TABLET, FILM COATED in 1 BOTTLE (35561-249-13)Marketed from Jan 1, 2021 |
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
- Bostal LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208476
- Marketing start
- Listing expires
- Identifiers
- Product ID 35561-249_55835cb2-d0ae-161d-e063-6394a90ac6cbSPL ID 55835cb2-d0ae-161d-e063-6394a90ac6cbSPL set ID 7eb328d0-4e6f-4b24-ae85-68c2b3657569RxCUI 477560, 477562UNII U202363UOSUPC 0335561249101, 0335561250114, 0335561250107, 0335561249132, 0335561250138, 0335561249118
- 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
N435561024903followed by a unit qualifier and the quantityPackage 35561-0249-03. 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-activated receptors (PPARα) 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 208476
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 | Bostal LLC | 35561-250 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-006 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-005 |