NDC codes

FDA NDC Directory
Product NDC (as listed)63304-443Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63304-0443Add 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
63304-443-0563304044305500 CAPSULE in 1 BOTTLE (63304-443-05)Marketed from Mar 2, 2015
63304-443-306330404433030 CAPSULE in 1 BOTTLE (63304-443-30)Marketed from Mar 2, 2015

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 — 43 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201748
Marketing start
Listing expires
Identifiers
Product ID 63304-443_54973b69-606a-d32e-e063-6394a90a997bSPL ID 54973b69-606a-d32e-e063-6394a90a997bSPL set ID 2083f5d9-92f2-4c64-b996-fabbd6946ea0RxCUI 483425, 483427UNII U202363UOSUPC 0363304443301, 0363304444902, 0363304444308
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

N463304044305 followed by a unit qualifier and the quantity

Package 63304-0443-05. 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)

Fenofibrate capsules, USP are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) (1). 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 (1). 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 (1). Fenofibrate did not reduce coronary heart disease morbidity and mor…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201748

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

FDA NDC Directory listings under ANDA 201748
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 130 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-310
FenofibrateFenofibrate 130 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.63304-444

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