What is NDC 33342-348?

33342-348 is the product NDC for Fenofibrate, Fenofibrate 160 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 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?

201 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 33342-348 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-348Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0348Add 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
33342-348-10	3334203481033342034810	90 TABLET in 1 CONTAINER (33342-348-10)Marketed from Jan 21, 2026
33342-348-12	3334203481233342034812	10 BLISTER PACK in 1 CARTON (33342-348-12) / 10 TABLET in 1 BLISTER PACKMarketed from Jan 21, 2026
33342-348-15	3334203481533342034815	500 TABLET in 1 CONTAINER (33342-348-15)Marketed from Jan 21, 2026

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 — 160 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 210379
Marketing start: Jan 21, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 33342-348_a504c42a-b629-4a21-a716-084962266b48SPL ID a504c42a-b629-4a21-a716-084962266b48SPL set ID a504c42a-b629-4a21-a716-084962266b48RxCUI 349287, 351133UNII U202363UOSUPC 0333342348159, 0333342347107, 0333342348104, 0333342347473
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

N433342034810 followed by a unit qualifier and the quantity

Package 33342-0348-10. 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 Mar 9, 2026.

Indications (excerpt from the label)

Fenofibrate tablets 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 cho…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-348

What is NDC 33342-348?: 33342-348 is the product NDC for Fenofibrate, Fenofibrate 160 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 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?: 201 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 48 mg/1	TabletOral	AvKARE	73190-015	73190-0015-90
Fenofibrate	Fenofibrate 145 mg/1	TabletOral	AvKARE	73190-016	73190-0016-90
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	A-S Medication Solutions	50090-7926	50090-7926-0050090-7926-01
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	A-S Medication Solutions	50090-7927	50090-7927-00
Fenofibrate	Fenofibrate 54 mg/1	TabletOral	NorthStar RxLLC	72603-840	72603-0840-01

All 202 Fenofibrate NDCs

Other NDCs under ANDA 210379

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

FDA NDC Directory listings under ANDA 210379
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 54 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-347