Prescription drug · ANDA
Fenofibrate NDC 43975-444
Fenofibrate 67 mg/1 · Capsule · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43975-444-10 | 43975044410 | 100 CAPSULE in 1 BOTTLE (43975-444-10)Marketed from May 1, 2018 |
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 — 67 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209504
- Marketing start
- Listing expires
- Identifiers
- Product ID 43975-444_379ca6d7-14ee-4c36-a271-325d231a2fbaSPL ID 379ca6d7-14ee-4c36-a271-325d231a2fbaSPL set ID c740f57c-cac5-4526-a5a9-aaab65b1caf6RxCUI 200311, 310288, 310289UNII U202363UOSUPC 0343975305108, 0343975444104, 0343975306105
- 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
N443975044410followed by a unit qualifier and the quantityPackage 43975-0444-10. 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)
INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209504
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 67 mg/1 | CapsuleOral | Coupler LLC | 67046-1538 |
| Fenofibrate | Fenofibrate 200 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 43975-306 |
| Fenofibrate | Fenofibrate 134 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 43975-305 |