Prescription drug · ANDA
Fenofibrate NDC 60687-853
Fenofibrate 54 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-853-21 | 60687085321 | 30 BLISTER PACK in 1 CARTON (60687-853-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-853-11)Marketed from Apr 19, 2025 |
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
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076433
- Marketing start
- Listing expires
- Identifiers
- Product ID 60687-853_2f0f3dde-ad02-363f-e063-6394a90a1073SPL ID 2f0f3dde-ad02-363f-e063-6394a90a1073SPL set ID 66761695-8630-49ff-8264-965dee246437RxCUI 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
N460687085321followed by a unit qualifier and the quantityPackage 60687-0853-21. 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, USP 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, USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076433
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 | Golden State Medical Supply, Inc. | 51407-093 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-864 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0741 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | Rhodes Pharmaceuticals LLC | 42858-454 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9474 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Rhodes Pharmaceuticals LLC | 42858-660 |