NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2369Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2369Add 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
68071-2369-96807123690990 TABLET, COATED in 1 BOTTLE (68071-2369-9)Marketed from Mar 17, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 48 mg/1
Dosage form
Tablet, Coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205118
Marketing start
Listing expires
Identifiers
Product ID 68071-2369_4b45622d-5001-33a3-e063-6394a90afb6eSPL ID 4b45622d-5001-33a3-e063-6394a90afb6eSPL set ID bdc2211e-6d65-1500-e053-2a95a90ab145RxCUI 477562UNII U202363UOSUPC 0368071236996
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

N468071236909 followed by a unit qualifier and the quantity

Package 68071-2369-09. 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 is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1 ). For treatment of adult patients with severe hypertriglyceridemia ( 1.2 ). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1 ). 1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (To…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205118

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

FDA NDC Directory listings under ANDA 205118
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 145 mg/1Tablet, CoatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-060
FenofibrateFenofibrate 48 mg/1Tablet, CoatedOralAurobindo Pharma Limited65862-768
FenofibrateFenofibrate 145 mg/1Tablet, CoatedOralAurobindo Pharma Limited65862-769
FenofibrateFenofibrate 48 mg/1Tablet, CoatedOralA-S Medication Solutions50090-3887
FenofibrateFenofibrate 48 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-1701

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