NDC codes

FDA NDC Directory
Product NDC (as listed)72789-310Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0310Add 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
72789-310-307278903103030 CAPSULE in 1 BOTTLE, PLASTIC (72789-310-30)Marketed from Mar 15, 2022

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 — 130 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 72789-310_4bbc4809-ec1c-375d-e063-6394a90a1cfcSPL ID 4bbc4809-ec1c-375d-e063-6394a90a1cfcSPL set ID 2f5cee5c-ec55-4e9b-9d54-e7f2f052130eRxCUI 483425UNII U202363UOSUPC 0372789310305
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

N472789031030 followed by a unit qualifier and the quantity

Package 72789-0310-30. 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/1CapsuleOralSun Pharmaceutical Industries, Inc.63304-444
FenofibrateFenofibrate 43 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.63304-443

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