What is NDC 67046-1538?

67046-1538 is the product NDC for Fenofibrate, Fenofibrate 67 mg/1 capsule, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. 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 67046-1538 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-1538Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-1538Add 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
67046-1538-3	6704615380367046153803	30 CAPSULE in 1 BLISTER PACK (67046-1538-3)Marketed from Mar 25, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 67 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209504
Marketing start: Mar 25, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 67046-1538_3134b1f0-2cc0-d83e-e063-6394a90a171dSPL ID 3134b1f0-2cc0-d83e-e063-6394a90a171dSPL set ID 3134b274-5dc0-cf90-e063-6294a90a252bRxCUI 200311UNII 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

N467046153803 followed by a unit qualifier and the quantity

Package 67046-1538-03. 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 Mar 25, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1538

What is NDC 67046-1538?: 67046-1538 is the product NDC for Fenofibrate, Fenofibrate 67 mg/1 capsule, listed with the FDA by Coupler 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?: Coupler LLC, NDC labeler code 67046. 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 209504

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

FDA NDC Directory listings under ANDA 209504
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 134 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	43975-305
Fenofibrate	Fenofibrate 200 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	43975-306
Fenofibrate	Fenofibrate 67 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	43975-444