Prescription drug · ANDA
Fenofibrate NDC 71335-2688
Fenofibrate 145 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2688-1 | 71335268801 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2688-1)Marketed from Sep 18, 2025 | |
| 71335-2688-2 | 71335268802 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2688-2)Marketed from Sep 18, 2025 | |
| 71335-2688-3 | 71335268803 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2688-3)Marketed from Sep 18, 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 — 145 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204598
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-2688_594eb16c-1d18-4a19-9bbe-70cfc442b930SPL ID 594eb16c-1d18-4a19-9bbe-70cfc442b930SPL set ID 8eee54d1-48ca-4704-93f3-0ac6fd7f464eRxCUI 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
N471335268801followed by a unit qualifier and the quantityPackage 71335-2688-01. 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)
Fenofibratetablets are indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible. Limitations of Use • Markedlyelevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7 )]. • Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized co…
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 | AvKARE | 42291-045 |
| 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 48 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-595 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-596 |