Prescription drug · NDA
Antara (fenofibrate) NDC 27437-108
Fenofibrate 90 mg/1 · Capsule · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Antara
- Generic name (nonproprietary)
- fenofibrate
- Active ingredients
- Fenofibrate — 90 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021695
- Marketing start
- Listing expires
- Identifiers
- Product ID 27437-108_7ca6a804-2dff-43b3-848e-7a58b31fb268SPL ID 7ca6a804-2dff-43b3-848e-7a58b31fb268SPL set ID 12ebf783-64df-4ffa-9e84-f8fdf4d245d4RxCUI 1442163, 1442165, 1442168, 1442170UNII U202363UOSUPC 0327437107066, 0327437108094
- 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.
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, randomized contro…
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 |
| Fenofibrate | Fenofibrate 130 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-131 |
| Antarafenofibrate | Fenofibrate 30 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-107 |
| Antarafenofibrate | Fenofibrate 43 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-109 |
| Antarafenofibrate | Fenofibrate 130 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-110 |