Prescription drug · ANDA
Fenofibrate NDC 71335-0891
Fenofibrate 48 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0891-1 | 71335089101 | 30 TABLET in 1 BOTTLE (71335-0891-1)Marketed from Apr 8, 2021 | |
| 71335-0891-2 | 71335089102 | 90 TABLET in 1 BOTTLE (71335-0891-2)Marketed from Jul 2, 2018 | |
| 71335-0891-3 | 71335089103 | 28 TABLET in 1 BOTTLE (71335-0891-3)Marketed from Dec 27, 2021 |
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 — 48 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 208709
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-0891_ee27b981-5895-4414-b4ec-a0663e72fdc5SPL ID ee27b981-5895-4414-b4ec-a0663e72fdc5SPL set ID b11f1c74-23da-4273-b504-0a2ca22c4b5aRxCUI 477562UNII 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
N471335089101followed by a unit qualifier and the quantityPackage 71335-0891-01. 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 is 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 are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholest…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208709
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 | TabletOral | Cipla USA Inc. | 69097-458 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | Cipla USA Inc. | 69097-459 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | A-S Medication Solutions | 50090-5327 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5101 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7161 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-234 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | A-S Medication Solutions | 50090-4031 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-866 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8530 |