NDC codes

FDA NDC Directory
Product NDC (as listed)69238-1261Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-1261Add 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
69238-1261-9692381261096923812610990 TABLET in 1 BOTTLE (69238-1261-9)Marketed from Feb 15, 2018

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
Route
Oral
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209951
Marketing start
Listing expires
Identifiers
Product ID 69238-1261_3c74b751-6125-4600-a38b-20eb97bbad16SPL ID 3c74b751-6125-4600-a38b-20eb97bbad16SPL set ID 283e754e-6ffa-4d6a-882f-9bbb3cbc8ca8RxCUI 477560, 477562UNII U202363UOSUPC 0369238126198, 0369238126099
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

N469238126109 followed by a unit qualifier and the quantity

Package 69238-1261-09. 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 tablets 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. Limitations of Use Markedly elevated 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 reduce coronary heart disease morbidity and mortality in two large, randomized cont…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-1261

What is NDC 69238-1261?
69238-1261 is the product NDC for Fenofibrate, Fenofibrate 145 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals NY 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?
Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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?
201 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 202 Fenofibrate NDCs

Other NDCs under ANDA 209951

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

FDA NDC Directory listings under ANDA 209951
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 48 mg/1TabletOralAmneal Pharmaceuticals NY LLC69238-1260
FenofibrateFenofibrate 48 mg/1TabletOralAvKARE73190-015
FenofibrateFenofibrate 145 mg/1TabletOralAvKARE73190-016

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