Prescription drug · NDA
Antara (Fenofibrate) NDC 27437-110
Fenofibrate 130 mg/1 · Capsule · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27437-110-06 | 2743701100627437011006 | 30 CAPSULE in 1 BOTTLE (27437-110-06)Marketed from Sep 25, 2009 |
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)
- Antara
- Generic name (nonproprietary)
- fenofibrate
- Active ingredients
- Fenofibrate — 130 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 27437-110_945dde7a-9442-4421-8bc8-7f7d6de013f8SPL ID 945dde7a-9442-4421-8bc8-7f7d6de013f8SPL set ID 24790a18-0291-4b88-a724-acac43b616ceRxCUI 483425, 483427, 578797, 578799UNII U202363UOSUPC 0327437110066, 0327437109060
- 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
N427437011006followed by a unit qualifier and the quantityPackage 27437-0110-06. 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 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 controlled trials…
Excerpt only. Read the full label for complete information.
About NDC 27437-110
- What is NDC 27437-110?
- 27437-110 is the product NDC for Antara (fenofibrate), Fenofibrate 130 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- 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 90 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-108 | — |
| Antarafenofibrate | Fenofibrate 43 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-109 | 27437-0109-06 |
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 90 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-108 |
| Antarafenofibrate | Fenofibrate 43 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 27437-109 |
| Fenofibrate | Fenofibrate 43 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-130 |
| Fenofibrate | Fenofibrate 130 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-131 |