NDC codes

FDA NDC Directory
Product NDC (as listed)27437-110Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27437-0110Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
27437-110-062743701100630 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
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

N427437011006 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021695

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021695
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 43 mg/1CapsuleOralLupin Pharmaceuticals, Inc.68180-130
FenofibrateFenofibrate 130 mg/1CapsuleOralLupin Pharmaceuticals, Inc.68180-131
AntarafenofibrateFenofibrate 30 mg/1CapsuleOralLupin Pharmaceuticals, Inc.27437-107
AntarafenofibrateFenofibrate 90 mg/1CapsuleOralLupin Pharmaceuticals, Inc.27437-108
AntarafenofibrateFenofibrate 43 mg/1CapsuleOralLupin Pharmaceuticals, Inc.27437-109

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