Prescription drug · ANDA
Fenofibrate NDC 60687-618
Fenofibrate 48 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-618-21 | 60687061821 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-618-21) / 1 TABLET in 1 BLISTER PACK (60687-618-11)Marketed from Aug 9, 2021 |
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
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090856
- Marketing start
- Listing expires
- Identifiers
- Product ID 60687-618_401cf11f-0460-cfda-e063-6394a90ab3dcSPL ID 401cf11f-0460-cfda-e063-6394a90ab3dcSPL set ID d1f64796-6ba0-415c-a6a0-5456b21a7ed6RxCUI 477560, 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
N460687061821followed by a unit qualifier and the quantityPackage 60687-0618-21. 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 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 USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (T…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090856
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 | Preferred Pharmaceuticals Inc. | 68788-4006 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-018 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | American Health Packaging | 60687-629 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7480 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-388 |
| Fenofibrate | Fenofibrate 145 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-389 |
| Fenofibrate | Fenofibrate 48 mg/1 | TabletOral | AvPAK | 50268-338 |