Fenofibrate NDC 0378-4390

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4390Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4390Add 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
0378-4390-77	00378439077	90 TABLET in 1 BOTTLE, PLASTIC (0378-4390-77)Marketed from Jun 23, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204475
Marketing start: Jun 23, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-4390_beac0c72-4b03-4b72-9568-db8a22571fe0SPL ID beac0c72-4b03-4b72-9568-db8a22571fe0SPL set ID 5b67f389-55e8-466b-82bd-5ea992f630aaRxCUI 749802, 749804UNII U202363UOSUPC 0303784390771, 0303784391778
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

N400378439077 followed by a unit qualifier and the quantity

Package 00378-4390-77. 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 Sep 15, 2025.

Indications (excerpt from the label)

Fenofibrate tablets are indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use • Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7) ] . • Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204475

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

FDA NDC Directory listings under ANDA 204475
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 120 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-4391