Fenofibrate NDC 35561-345

NDC codes

FDA NDC Directory

Product NDC (as listed)35561-345Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35561-0345Add 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 NDC	11-digit (billing)	Package
35561-345-11	35561034511	90 CAPSULE in 1 BOTTLE (35561-345-11)Marketed from Nov 17, 2017
35561-345-12	35561034512	100 CAPSULE in 1 BOTTLE (35561-345-12)Marketed from Nov 20, 2020
35561-345-13	35561034513	500 CAPSULE in 1 BOTTLE (35561-345-13)Marketed from Nov 20, 2020

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 — 67 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Bostal LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207805
Marketing start: Nov 17, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 35561-345_5097ee14-8bcd-10bb-e063-6394a90aa196SPL ID 5097ee14-8bcd-10bb-e063-6394a90aa196SPL set ID a5bc232c-ff27-f8b6-e053-2995a90ad399RxCUI 200311, 310288, 310289UNII U202363UOS
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

N435561034511 followed by a unit qualifier and the quantity

Package 35561-0345-11. 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 Apr 29, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate capsules 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 are also indicated as adjunctive therapy to diet for treatment of adult patients with …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207805

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

FDA NDC Directory listings under ANDA 207805
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 134 mg/1	CapsuleOral	Bostal LLC	35561-346
Fenofibrate	Fenofibrate 200 mg/1	CapsuleOral	Bostal LLC	35561-347