Prescription drug · ANDA
Fenofibrate NDC 65862-768
Fenofibrate 48 mg/1 · Tablet, Coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-768-01 | 65862076801 | 100 TABLET, COATED in 1 BOTTLE (65862-768-01)Marketed from May 5, 2016 | |
| 65862-768-05 | 65862076805 | 500 TABLET, COATED in 1 BOTTLE (65862-768-05)Marketed from May 5, 2016 | |
| 65862-768-78 | 65862076878 | 10 BLISTER PACK in 1 CARTON (65862-768-78) / 10 TABLET, COATED in 1 BLISTER PACK (65862-768-10)Marketed from May 5, 2016 | |
| 65862-768-90 | 65862076890 | 90 TABLET, COATED in 1 BOTTLE (65862-768-90)Marketed from May 5, 2016 | |
| 65862-768-99 | 65862076899 | 1000 TABLET, COATED in 1 BOTTLE (65862-768-99)Marketed from May 5, 2016 |
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, Coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205118
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-768_05013562-2f49-4b1f-a8eb-5925f3d3beadSPL ID 05013562-2f49-4b1f-a8eb-5925f3d3beadSPL set ID 84fcea7a-05ed-44c2-98fa-7e87b28d2261RxCUI 477560, 477562UNII U202363UOSUPC 0365862768902
- 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
N465862076801followed by a unit qualifier and the quantityPackage 65862-0768-01. 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 indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with 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 not possible. Limitations of Use Markedly elevated 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 reduce coronary heart disease morbidity and mortality in two large, randomized contr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205118
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, CoatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-060 |
| Fenofibrate | Fenofibrate 145 mg/1 | Tablet, CoatedOral | Aurobindo Pharma Limited | 65862-769 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-2369 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-3887 |
| Fenofibrate | Fenofibrate 48 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-1701 |