What is NDC 82009-060?

82009-060 is the product NDC for Fenofibrate, Fenofibrate 145 mg/1 tablet, coated, listed with the FDA by QUALLENT PHARMACEUTICALS HEALTH LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

QUALLENT PHARMACEUTICALS HEALTH LLC, NDC labeler code 82009. 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 82009-060 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82009-060Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82009-0060Add 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
82009-060-90	8200900609082009006090	90 TABLET, COATED in 1 BOTTLE (82009-060-90)Marketed from Nov 18, 2022

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 — 145 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: QUALLENT PHARMACEUTICALS HEALTH LLCNDC labeler code 82009
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205118
Marketing start: Nov 18, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 82009-060_483b124e-3ea2-42d6-a1a8-8617df9932deSPL ID 483b124e-3ea2-42d6-a1a8-8617df9932deSPL set ID 215a5000-9f89-47d9-b2d5-94e13f5e1767RxCUI 477560UNII 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

N482009006090 followed by a unit qualifier and the quantity

Package 82009-0060-90. 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, randomized contr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82009-060

What is NDC 82009-060?: 82009-060 is the product NDC for Fenofibrate, Fenofibrate 145 mg/1 tablet, coated, listed with the FDA by QUALLENT PHARMACEUTICALS HEALTH LLC. It has 1 package NDC, 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?: QUALLENT PHARMACEUTICALS HEALTH LLC, NDC labeler code 82009. 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 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

All 204 Fenofibrate NDCs

Other NDCs under ANDA 205118

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

FDA NDC Directory listings under ANDA 205118
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 48 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-3887
Fenofibrate	Fenofibrate 145 mg/1	Tablet, CoatedOral	Aurobindo Pharma Limited	65862-769
Fenofibrate	Fenofibrate 48 mg/1	Tablet, CoatedOral	NuCare Pharmaceuticals,Inc.	68071-2369
Fenofibrate	Fenofibrate 48 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	71335-1701