Prescription drug · ANDA
Fenofibrate NDC 68180-389
Fenofibrate 145 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-389-02 | 68180038902 | 500 TABLET in 1 BOTTLE (68180-389-02)Marketed from Aug 1, 2020 | |
| 68180-389-09 | 68180038909 | 90 TABLET in 1 BOTTLE (68180-389-09)Marketed from Aug 1, 2020 |
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 — 145 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090856
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-389_e454c5bc-7a0e-4d5e-95fb-ccf812747a3cSPL ID e454c5bc-7a0e-4d5e-95fb-ccf812747a3cSPL set ID 45364845-c3b4-40a1-a677-82202ffaa5adRxCUI 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
N468180038902followed by a unit qualifier and the quantityPackage 68180-0389-02. 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 USP is indicated as adjunctive therapy to diet: To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7 )] . Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized c…
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 48 mg/1 | TabletOral | American Health Packaging | 60687-618 |
| 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 48 mg/1 | TabletOral | AvPAK | 50268-338 |