NDC codes

FDA NDC Directory
Product NDC (as listed)27241-119Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27241-0119Add 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
27241-119-0427241011904100 CAPSULE in 1 BOTTLE (27241-119-04)Marketed from Sep 10, 2018
27241-119-0527241011905500 CAPSULE in 1 BOTTLE (27241-119-05)Marketed from Aug 1, 2019

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 — 134 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210705
Marketing start
Listing expires
Identifiers
Product ID 27241-119_2dffe879-0f18-4961-b1a9-0d69565a04a6SPL ID 2dffe879-0f18-4961-b1a9-0d69565a04a6SPL set ID da2f0ba4-7c16-4fb0-bc1c-45540e8fefbfRxCUI 200311, 310288, 310289UNII U202363UOSUPC 0327241119040, 0327241118043, 0327241120046
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

N427241011904 followed by a unit qualifier and the quantity

Package 27241-0119-04. 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)

INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate capsules, USP are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia Fenofibrate capsules, USP are also indicated as adjunctive therapy to diet for treatment of adult pati…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210705

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

FDA NDC Directory listings under ANDA 210705
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 200 mg/1CapsuleOralAjanta Pharma USA Inc.27241-120
FenofibrateFenofibrate 67 mg/1CapsuleOralAjanta Pharma USA Inc.27241-118

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