Fenofibrate NDC 43975-306

NDC codes

FDA NDC Directory

Product NDC (as listed)43975-306Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43975-0306Add 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	Copy
43975-306-10	43975030610	100 CAPSULE in 1 BOTTLE (43975-306-10)Marketed from May 1, 2018
43975-306-50	43975030650	500 CAPSULE in 1 BOTTLE (43975-306-50)Marketed from May 1, 2018

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 — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209504
Marketing start: May 1, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 43975-306_379ca6d7-14ee-4c36-a271-325d231a2fbaSPL ID 379ca6d7-14ee-4c36-a271-325d231a2fbaSPL set ID c740f57c-cac5-4526-a5a9-aaab65b1caf6RxCUI 200311, 310288, 310289UNII U202363UOSUPC 0343975305108, 0343975444104, 0343975306105
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

N443975030610 followed by a unit qualifier and the quantity

Package 43975-0306-10. 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 Jul 28, 2025.

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 209504

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

FDA NDC Directory listings under ANDA 209504
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 67 mg/1	CapsuleOral	Coupler LLC	67046-1538
Fenofibrate	Fenofibrate 134 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	43975-305
Fenofibrate	Fenofibrate 67 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	43975-444