What is NDC 33342-339?

33342-339 is the product NDC for Fenofibrate, Fenofibrate 48 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fenofibrate?

203 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fenofibrate NDC 33342-339 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-339Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0339Add 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
33342-339-07	33342033907	30 TABLET in 1 BOTTLE (33342-339-07)Marketed from Nov 13, 2024
33342-339-10	33342033910	90 TABLET in 1 BOTTLE (33342-339-10)Marketed from Nov 13, 2024
33342-339-12	33342033912	10 BLISTER PACK in 1 CARTON (33342-339-12) / 10 TABLET in 1 BLISTER PACKMarketed from Nov 13, 2024
33342-339-15	33342033915	500 TABLET in 1 BOTTLE (33342-339-15)Marketed from Nov 13, 2024

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 — 48 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210248
Marketing start: Nov 13, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 33342-339_ab7aad70-2879-4260-831e-cbfbe8be73b2SPL ID ab7aad70-2879-4260-831e-cbfbe8be73b2SPL set ID e8b9d1f5-0541-424f-b1d4-bef6381aa934RxCUI 477560, 477562UNII U202363UOSUPC 0333342339157, 0333342340108
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

N433342033907 followed by a unit qualifier and the quantity

Package 33342-0339-07. 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 9, 2025.

Indications (excerpt from the label)

Fenofibrate tablets is 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, randomize…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-339

What is NDC 33342-339?: 33342-339 is the product NDC for Fenofibrate, Fenofibrate 48 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fenofibrate.
What is the active ingredient?: Fenofibrate.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fenofibrate?: 203 other product NDCs are listed under this name. See all Fenofibrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fenofibrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fenofibrate	Fenofibrate 54 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4721	70518-4721-00
Fenofibrate	Fenofibrate 145 mg/1	TabletOral	REMEDYREPACK INC.	70518-4672	70518-4672-00
Fenofibrate	Fenofibrate 48 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-039	48433-0039-20
Fenofibrate	Fenofibrate 145 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-040	48433-0040-20
Fenofibrate	Fenofibrate 54 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-347	33342-0347-1033342-0347-1233342-0347-47
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-348	33342-0348-1033342-0348-1233342-0348-15
Fenofibrate	Fenofibrate 48 mg/1	TabletOral	AvKARE	73190-015	73190-0015-90
Fenofibrate	Fenofibrate 145 mg/1	TabletOral	AvKARE	73190-016	73190-0016-90
Fenofibrate	Fenofibrate 54 mg/1	TabletOral	NorthStar RxLLC	72603-840	72603-0840-01
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	NorthStar RxLLC	72603-841	72603-0841-0172603-0841-02

All 204 Fenofibrate NDCs

Other NDCs under ANDA 210248

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

FDA NDC Directory listings under ANDA 210248
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 145 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-340