Fenofibrate NDC 55111-349

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-349Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0349Add 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
55111-349-01	55111034901	100 CAPSULE in 1 BOTTLE (55111-349-01)Marketed from Apr 7, 2014
55111-349-30	55111034930	30 CAPSULE in 1 BOTTLE (55111-349-30)Marketed from Apr 7, 2014

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 — 43 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Dr. Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090859
Marketing start: Apr 7, 2014
Listing expires: Dec 31, 2026
Identifiers: Product ID 55111-349_e12ef2fc-f146-a40f-d71c-96a144518d82SPL ID e12ef2fc-f146-a40f-d71c-96a144518d82SPL set ID 16ea8ce4-8c1c-4111-509e-86aa688d89a0RxCUI 483425, 483427UNII 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

N455111034901 followed by a unit qualifier and the quantity

Package 55111-0349-01. 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 Dec 28, 2018.

Indications (excerpt from the label)

Fenofibrate capsule is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1) . to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (1.2) . Important 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 and Mixed Dyslipidemia Fenofibrate capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotei…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090859

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

FDA NDC Directory listings under ANDA 090859
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 130 mg/1	CapsuleOral	Dr. Reddy's Laboratories Limited	55111-395