NDC codes

FDA NDC Directory
Product NDC (as listed)62559-461Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62559-0461Add 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
62559-461-906255904619090 CAPSULE in 1 BOTTLE (62559-461-90)Marketed from Apr 13, 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 — 150 mg/1
Dosage form
Capsule
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021612
Marketing start
Listing expires
Identifiers
Product ID 62559-461_9938193b-bd47-4176-9e2e-840f09112fffSPL ID 9938193b-bd47-4176-9e2e-840f09112fffSPL set ID 3a69e15a-eda6-4a6e-8934-6881e4370521RxCUI 616852, 616853UNII U202363UOSUPC 0362559461900, 0362559460903
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

N462559046190 followed by a unit qualifier and the quantity

Package 62559-0461-90. 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)

Fenofibrate capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with 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 not possible. Fenofibrate capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) ( 1 ) to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62559-461

What is NDC 62559-461?
62559-461 is the product NDC for Fenofibrate, Fenofibrate 150 mg/1 capsule, listed with the FDA by ANI Pharmaceuticals, Inc.. 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?
ANI Pharmaceuticals, Inc., NDC labeler code 62559. 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
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 203 Fenofibrate NDCs

Other NDCs under NDA 021612

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

FDA NDC Directory listings under NDA 021612
ProductStrengthForm · routeLabelerProduct NDC
LipofenfenofibrateFenofibrate 150 mg/1CapsuleOralANI Pharmaceuticals, Inc.62559-306
LipofenfenofibrateFenofibrate 50 mg/1CapsuleOralANI Pharmaceuticals, Inc.62559-305
FenofibrateFenofibrate 50 mg/1CapsuleOralANI Pharmaceuticals, Inc.62559-460

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