Prescription drug · ANDA
Fenofibrate NDC 71335-2629
Fenofibrate 120 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2629-1 | 71335262901 | 90 TABLET in 1 BOTTLE (71335-2629-1)Marketed from Apr 14, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 120 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217732
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-2629_338d03b2-c34f-6e24-e063-6394a90a3c39SPL ID 338d03b2-c34f-6e24-e063-6394a90a3c39SPL set ID 338d03b2-c34e-6e24-e063-6394a90a3c39RxCUI 749802, 749804UNII 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
N471335262901followed by a unit qualifier and the quantityPackage 71335-2629-01. 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 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 ) to treat adult patients with severe hypertriglyceridemia. ( 1.2 ) Important Limitation 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 and Mixed Dyslipidemia Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholestero…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217732
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 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2628 |
| Fenofibrate | Fenofibrate 120 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2470 |
| Fenofibrate | Fenofibrate 40 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2469 |
| Fenofibrate | Fenofibrate 40 mg/1 | TabletOral | Trifluent Pharma LLC | 73352-101 |
| Fenofibrate | Fenofibrate 120 mg/1 | TabletOral | Trifluent Pharma LLC | 73352-102 |
| Fenofibrate | Fenofibrate 40 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-101 |
| Fenofibrate | Fenofibrate 120 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-102 |