NDC codes

FDA NDC Directory
Product NDC (as listed)68180-231Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0231Add 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
68180-231-096818002310990 TABLET in 1 BOTTLE (68180-231-09)Marketed from Jul 1, 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
Route
Oral
Labeler
Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204019
Marketing start
Listing expires
Identifiers
Product ID 68180-231_a70e38c8-07c1-4df6-8c2b-b5e0df3c304dSPL ID a70e38c8-07c1-4df6-8c2b-b5e0df3c304dSPL set ID 4cb6617c-f787-470f-81d8-0aba46df937fRxCUI 349287, 351133UNII U202363UOSUPC 0368180232094, 0368180231097
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

N468180023109 followed by a unit qualifier and the quantity

Package 68180-0231-09. 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 tablet USP 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 tablet USP is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total ch…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-231

What is NDC 68180-231?
68180-231 is the product NDC for Fenofibrate, Fenofibrate 54 mg/1 tablet, listed with the FDA by Lupin 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?
Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 145 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-04048433-0040-20
FenofibrateFenofibrate 48 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-03948433-0039-20
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 145 mg/1TabletOralAvKARE73190-01673190-0016-90
FenofibrateFenofibrate 48 mg/1TabletOralAvKARE73190-01573190-0015-90
FenofibrateFenofibrate 54 mg/1TabletOralNorthStar RxLLC72603-84072603-0840-01
FenofibrateFenofibrate 160 mg/1TabletOralNorthStar RxLLC72603-84172603-0841-0172603-0841-02

All 204 Fenofibrate NDCs

Other NDCs under ANDA 204019

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

FDA NDC Directory listings under ANDA 204019
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 160 mg/1TabletOralA-S Medication Solutions50090-5854
FenofibrateFenofibrate 160 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-232
FenofibrateFenofibrate 54 mg/1TabletOralA-S Medication Solutions50090-6227

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Fenofibrate NDC 68180-231 | National Drug Code | Med-Code