Prescription drug · NDA AUTHORIZED GENERIC
Fenofibrate NDC 68180-131
Fenofibrate 130 mg/1 · Capsule · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-131-06 | 68180013106 | 30 CAPSULE in 1 BOTTLE (68180-131-06)Marketed from Feb 22, 2013 |
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 — 130 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021695
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-131_00a3d4e3-2364-47fd-919a-f336c12ece0dSPL ID 00a3d4e3-2364-47fd-919a-f336c12ece0dSPL set ID 37b25526-0bd0-4459-a4be-f3a6893506f9RxCUI 483425, 483427UNII U202363UOSUPC 0368180131069, 0368180130062
- 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
N468180013106followed by a unit qualifier and the quantityPackage 68180-0131-06. 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)
Antara 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 triglycerides (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, randomiz…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021695
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 43 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-130 |
| Antarafenofibrate | Fenofibrate 30 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-107 |
| Antarafenofibrate | Fenofibrate 90 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-108 |
| Antarafenofibrate | Fenofibrate 43 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-109 |
| Antarafenofibrate | Fenofibrate 130 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-110 |