Prescription drug · ANDA
Fenofibrate NDC 71205-666
Fenofibrate 54 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-666-30 | 71205066630 | 30 TABLET in 1 BOTTLE (71205-666-30)Marketed from Jun 1, 2022 | |
| 71205-666-60 | 71205066660 | 60 TABLET in 1 BOTTLE (71205-666-60)Marketed from Jun 1, 2022 | |
| 71205-666-90 | 71205066690 | 90 TABLET in 1 BOTTLE (71205-666-90)Marketed from Jun 1, 2022 |
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
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213864
- Marketing start
- Listing expires
- Identifiers
- Product ID 71205-666_26f8f793-fb7a-4327-9441-d8737fe1ff11SPL ID 26f8f793-fb7a-4327-9441-d8737fe1ff11SPL set ID 26f8f793-fb7a-4327-9441-d8737fe1ff11RxCUI 351133UNII U202363UOSUPC 0371205666309
- 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
N471205066630followed by a unit qualifier and the quantityPackage 71205-0666-30. 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 is 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 cholesterol (…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213864
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 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-7926 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-7927 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-214 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-215 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7539 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-318 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7816 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-856 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | NorthStar RxLLC | 72603-841 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | NorthStar RxLLC | 72603-840 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1756 |
| Fenofibrate | Fenofibrate 160 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2907 |
| Fenofibrate | Fenofibrate 54 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2947 |