Fenofibrate NDC 69238-1262

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1262Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1262Add 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
69238-1262-9	69238126209	90 TABLET in 1 BOTTLE (69238-1262-9)Marketed from Mar 23, 2018

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 — 54 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209950
Marketing start: Mar 23, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 69238-1262_83cbfdb7-7c9b-437a-95da-c0a800e7cb60SPL ID 83cbfdb7-7c9b-437a-95da-c0a800e7cb60SPL set ID 7e79d495-5d59-485e-b3c2-7c31ba044948RxCUI 349287, 351133UNII U202363UOSUPC 0369238126297, 0369238126396
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

N469238126209 followed by a unit qualifier and the quantity

Package 69238-1262-09. 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 Mar 30, 2021.

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 209950

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

FDA NDC Directory listings under ANDA 209950
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	69238-1263