What is NDC 42385-935?

42385-935 is the product NDC for Fenofibrate, Fenofibrate 54 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Laurus Labs Limited, NDC labeler code 42385. 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?

202 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 42385-935 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-935Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0935Add 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
42385-935-05	42385093505	500 TABLET, FILM COATED in 1 BOTTLE (42385-935-05)Marketed from Jan 13, 2020
42385-935-11	42385093511	1000 TABLET, FILM COATED in 1 BOTTLE (42385-935-11)Marketed from Jan 13, 2020
42385-935-30	42385093530	30 TABLET, FILM COATED in 1 BOTTLE (42385-935-30)Marketed from Jan 13, 2020
42385-935-90	42385093590	90 TABLET, FILM COATED in 1 BOTTLE (42385-935-90)Marketed from Jan 13, 2020

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 — 54 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Laurus Labs LimitedNDC labeler code 42385
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210606
Marketing start: Jan 13, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 42385-935_f0dfffd1-9c2c-0cbd-e053-2a95a90a908cSPL ID f0dfffd1-9c2c-0cbd-e053-2a95a90a908cSPL set ID 8e58c13a-8088-4fed-86cc-52530de5aa45RxCUI 349287, 351133UNII U202363UOSUPC 0342385936902, 0342385935905
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

N442385093505 followed by a unit qualifier and the quantity

Package 42385-0935-05. 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, 2022.

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 (To…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42385-935

What is NDC 42385-935?: 42385-935 is the product NDC for Fenofibrate, Fenofibrate 54 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. 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?: Laurus Labs Limited, NDC labeler code 42385. 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?: 202 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 203 Fenofibrate NDCs

Other NDCs under ANDA 210606

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

FDA NDC Directory listings under ANDA 210606
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 160 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-936
Fenofibrate	Fenofibrate 54 mg/1	Tablet, Film coatedOral	Leading Pharma, LLC	69315-289
Fenofibrate	Fenofibrate 160 mg/1	Tablet, Film coatedOral	Leading Pharma, LLC	69315-290