What is NDC 0115-5522?

0115-5522 is the product NDC for Fenofibrate, Fenofibrate 160 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 0115-5522 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-5522Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-5522Add 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
0115-5522-01	00115552201	100 TABLET in 1 BOTTLE (0115-5522-01)Marketed from Feb 1, 2010
0115-5522-02	00115552202	500 TABLET in 1 BOTTLE (0115-5522-02)Marketed from Feb 1, 2010
0115-5522-03	00115552203	1000 TABLET in 1 BOTTLE (0115-5522-03)Marketed from Feb 1, 2010
0115-5522-10	00115552210	90 TABLET in 1 BOTTLE (0115-5522-10)Marketed from Feb 1, 2010

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 — 160 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076509
Marketing start: Feb 1, 2010
Listing expires: Dec 31, 2026
Identifiers: Product ID 0115-5522_71bb776c-1208-4049-bba2-0f9eb1ea4efeSPL ID 71bb776c-1208-4049-bba2-0f9eb1ea4efeSPL set ID fa08cf6a-d306-4979-9b23-ac7febf4fd12RxCUI 349287, 351133UNII U202363UOSUPC 0301155522103
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

N400115552201 followed by a unit qualifier and the quantity

Package 00115-5522-01. 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 Apr 1, 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 (T…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-5522

What is NDC 0115-5522?: 0115-5522 is the product NDC for Fenofibrate, Fenofibrate 160 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 145 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-040	48433-0040-20
Fenofibrate	Fenofibrate 48 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-039	48433-0039-20
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 145 mg/1	TabletOral	AvKARE	73190-016	73190-0016-90
Fenofibrate	Fenofibrate 48 mg/1	TabletOral	AvKARE	73190-015	73190-0015-90
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 076509

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

FDA NDC Directory listings under ANDA 076509
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 54 mg/1	TabletOral	AvPAK	50268-312
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	AvPAK	50268-313
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	A-S Medication Solutions	50090-6974
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	A-S Medication Solutions	50090-6973
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	Northwind Health Company, LLC	51655-009
Fenofibrate	Fenofibrate 54 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	0115-5511
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	REMEDYREPACK INC.	70518-4326
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-410
Fenofibrate	Fenofibrate 54 mg/1	TabletOral	Amneal Pharmaceuticals LLC	60219-5511
Fenofibrate	Fenofibrate 160 mg/1	TabletOral	Amneal Pharmaceuticals LLC	60219-5522