NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8106Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8106Add 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 NDC11-digit (billing)PackageCopy
68788-8106-16878881060168788810601100 TABLET, FILM COATED in 1 BOTTLE (68788-8106-1)Marketed from Nov 3, 2021
68788-8106-3687888106036878881060330 TABLET, FILM COATED in 1 BOTTLE (68788-8106-3)Marketed from Nov 3, 2021
68788-8106-6687888106066878881060660 TABLET, FILM COATED in 1 BOTTLE (68788-8106-6)Marketed from Nov 3, 2021
68788-8106-9687888106096878881060990 TABLET, FILM COATED in 1 BOTTLE (68788-8106-9)Marketed from Nov 3, 2021

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 — 145 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Preferred Pharmaceuticals, Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204598
Marketing start
Listing expires
Identifiers
Product ID 68788-8106_5ceb6b11-4988-4426-9299-c8a2a98fd175SPL ID 5ceb6b11-4988-4426-9299-c8a2a98fd175SPL set ID c810b16b-32e2-4d0c-aa28-bf1f62110757RxCUI 477560UNII 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

N468788810601 followed by a unit qualifier and the quantity

Package 68788-8106-01. 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 .

Indications (excerpt from the label)

Fenofibratetablets are indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adultswith severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is notpossible. Limitations of Use • Markedlyelevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7 )]. • Fenofibrate did not reducecoronary heart disease morbidity and mortality in two large, randomized co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8106

What is NDC 68788-8106?
68788-8106 is the product NDC for Fenofibrate, Fenofibrate 145 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals, Inc.. 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?
Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FenofibrateFenofibrate 54 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-472170518-4721-00
FenofibrateFenofibrate 145 mg/1TabletOralREMEDYREPACK INC.70518-467270518-4672-00
FenofibrateFenofibrate 48 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-03948433-0039-20
FenofibrateFenofibrate 145 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-04048433-0040-20
FenofibrateFenofibrate 54 mg/1TabletOralMacleods Pharmaceuticals Limited33342-34733342-0347-1033342-0347-1233342-0347-47
FenofibrateFenofibrate 160 mg/1TabletOralMacleods Pharmaceuticals Limited33342-34833342-0348-1033342-0348-1233342-0348-15
FenofibrateFenofibrate 48 mg/1TabletOralAvKARE73190-01573190-0015-90
FenofibrateFenofibrate 145 mg/1TabletOralAvKARE73190-01673190-0016-90
FenofibrateFenofibrate 160 mg/1TabletOralA-S Medication Solutions50090-792650090-7926-0050090-7926-01
FenofibrateFenofibrate 160 mg/1TabletOralA-S Medication Solutions50090-792750090-7927-00

All 204 Fenofibrate NDCs

Other NDCs under ANDA 204598

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

FDA NDC Directory listings under ANDA 204598
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 48 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-595
FenofibrateFenofibrate 145 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-596
FenofibrateFenofibrate 145 mg/1Tablet, Film coatedOralAvKARE42291-045
FenofibrateFenofibrate 145 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3044
FenofibrateFenofibrate 48 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3056
FenofibrateFenofibrate 48 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2654
FenofibrateFenofibrate 145 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2688

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