Fenofibrate NDC 65862-768

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-768Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0768Add 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
65862-768-01	65862076801	100 TABLET, COATED in 1 BOTTLE (65862-768-01)Marketed from May 5, 2016
65862-768-05	65862076805	500 TABLET, COATED in 1 BOTTLE (65862-768-05)Marketed from May 5, 2016
65862-768-78	65862076878	10 BLISTER PACK in 1 CARTON (65862-768-78) / 10 TABLET, COATED in 1 BLISTER PACK (65862-768-10)Marketed from May 5, 2016
65862-768-90	65862076890	90 TABLET, COATED in 1 BOTTLE (65862-768-90)Marketed from May 5, 2016
65862-768-99	65862076899	1000 TABLET, COATED in 1 BOTTLE (65862-768-99)Marketed from May 5, 2016

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, Coated
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205118
Marketing start: May 5, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 65862-768_05013562-2f49-4b1f-a8eb-5925f3d3beadSPL ID 05013562-2f49-4b1f-a8eb-5925f3d3beadSPL set ID 84fcea7a-05ed-44c2-98fa-7e87b28d2261RxCUI 477560, 477562UNII U202363UOSUPC 0365862768902
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

N465862076801 followed by a unit qualifier and the quantity

Package 65862-0768-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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 145 mg/1	Tablet, CoatedOral	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-060
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	A-S Medication Solutions	50090-3887
Fenofibrate	Fenofibrate 48 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	71335-1701