What is NDC 55111-395?

55111-395 is the product NDC for Fenofibrate, Fenofibrate 130 mg/1 capsule, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 55111-395 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-395Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0395Add 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
55111-395-01	5511103950155111039501	100 CAPSULE in 1 BOTTLE (55111-395-01)Marketed from Apr 7, 2014
55111-395-30	5511103953055111039530	30 CAPSULE in 1 BOTTLE (55111-395-30)Marketed from Apr 7, 2014
55111-395-90	5511103959055111039590	90 CAPSULE in 1 BOTTLE (55111-395-90)Marketed from Apr 7, 2014

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 — 130 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090859
Marketing start: Apr 7, 2014
Listing expires: Dec 31, 2027
Identifiers: Product ID 55111-395_e12ef2fc-f146-a40f-d71c-96a144518d82SPL ID e12ef2fc-f146-a40f-d71c-96a144518d82SPL set ID 16ea8ce4-8c1c-4111-509e-86aa688d89a0RxCUI 483425, 483427UNII 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

N455111039501 followed by a unit qualifier and the quantity

Package 55111-0395-01. 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 Dec 28, 2018.

Indications (excerpt from the label)

Fenofibrate capsule is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1) . to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (1.2) . Important 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 and Mixed Dyslipidemia Fenofibrate capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotei…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-395

What is NDC 55111-395?: 55111-395 is the product NDC for Fenofibrate, Fenofibrate 130 mg/1 capsule, listed with the FDA by Dr. Reddy's Laboratories 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?: Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 090859

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

FDA NDC Directory listings under ANDA 090859
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 43 mg/1	CapsuleOral	Dr. Reddy's Laboratories Limited	55111-349