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.NDC labeler code 27437
- 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.
About NDC 27437-108
- What is NDC 27437-108?
- 27437-108 is the product NDC for Antara (fenofibrate), Fenofibrate 90 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Antara (Fenofibrate).
- What is the active ingredient?
- Fenofibrate.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 27437. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Antara?
- 3 other product NDCs are listed under this name. See all Antara NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Antara products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Antarafenofibrate | Fenofibrate 30 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-107 | — |
| Antarafenofibrate | Fenofibrate 43 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-109 | 27437-0109-06 |
| Antarafenofibrate | Fenofibrate 130 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-110 | 27437-0110-06 |
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 |
|---|---|---|---|---|
| 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 |
| Fenofibrate | Fenofibrate 43 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-130 |
| Fenofibrate | Fenofibrate 130 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-131 |