What is NDC 69097-895?

69097-895 is the product NDC for Fenofibrate, Fenofibrate 134 mg/1 capsule, listed with the FDA by Cipla USA Inc.,. It has 3 package NDCs, shown above in 10- and 11-digit form.

Cipla USA Inc.,, NDC labeler code 69097. 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 69097-895 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-895Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0895Add 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
69097-895-02	6909708950269097089502	30 CAPSULE in 1 BOTTLE, PLASTIC (69097-895-02)Marketed from Mar 30, 2017
69097-895-07	6909708950769097089507	100 CAPSULE in 1 BOTTLE, PLASTIC (69097-895-07)Marketed from Mar 30, 2017
69097-895-12	6909708951269097089512	500 CAPSULE in 1 BOTTLE, PLASTIC (69097-895-12)Marketed from Mar 30, 2017

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 — 134 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Cipla USA Inc.,NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207378
Marketing start: Mar 30, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 69097-895_06d917b6-6950-4b49-b830-a1fa0b8ac0b1SPL ID 06d917b6-6950-4b49-b830-a1fa0b8ac0b1SPL set ID 07d47c02-ab29-4ba9-aea0-96ffbd70c0efRxCUI 200311, 310288, 310289UNII U202363UOSUPC 0369097896072, 0369097895075
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

N469097089502 followed by a unit qualifier and the quantity

Package 69097-0895-02. 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 Jan 20, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate capsules, USP are indicated as adjunctive therapy to diet for the reduction of LDLC, 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, USP are also indicated as adjunctive therapy to diet for treatment of adult pati…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-895

What is NDC 69097-895?: 69097-895 is the product NDC for Fenofibrate, Fenofibrate 134 mg/1 capsule, listed with the FDA by Cipla USA Inc.,. 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?: Cipla USA Inc.,, NDC labeler code 69097. 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 207378

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

FDA NDC Directory listings under ANDA 207378
Product	Strength	Form · route	Labeler	Product NDC
Fenofibrate	Fenofibrate 67 mg/1	CapsuleOral	Cipla USA Inc.,	69097-894
Fenofibrate	Fenofibrate 200 mg/1	CapsuleOral	Cipla USA Inc.,	69097-896