Prescription drug · ANDA
Fenofibrate NDC 46708-554
Fenofibrate 54 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-554-90 | 46708055490 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-554-90)Marketed from Aug 1, 2019 |
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, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209660
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-554_037d6074-3c99-4fdc-99f0-f0b58bdbb874SPL ID 037d6074-3c99-4fdc-99f0-f0b58bdbb874SPL set ID 39e61e9d-dda8-4989-a3dd-79545a5c9157RxCUI 349287, 351133UNII 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
N446708055490followed by a unit qualifier and the quantityPackage 46708-0554-90. 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 tablet 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 tablet is 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 209660
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 54 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-554 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-555 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-555 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-837 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-838 |
| Fenofibrate | Fenofibrate 54 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-538 |
| Fenofibrate | Fenofibrate 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-539 |