NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3887Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3887Add 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
50090-3887-05009038870090 TABLET, COATED in 1 BOTTLE (50090-3887-0)Marketed from Nov 30, 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 — 48 mg/1
Dosage form
Tablet, Coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205118
Marketing start
Listing expires
Identifiers
Product ID 50090-3887_45fc8d9c-29e8-4409-bb22-f32411c84efdSPL ID 45fc8d9c-29e8-4409-bb22-f32411c84efdSPL set ID d0c7070e-b3bb-4b5b-8a62-4e3136b5acccRxCUI 477562UNII 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

N450090388700 followed by a unit qualifier and the quantity

Package 50090-3887-00. 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 contr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205118

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

FDA NDC Directory listings under ANDA 205118
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 145 mg/1Tablet, CoatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-060
FenofibrateFenofibrate 48 mg/1Tablet, CoatedOralAurobindo Pharma Limited65862-768
FenofibrateFenofibrate 145 mg/1Tablet, CoatedOralAurobindo Pharma Limited65862-769
FenofibrateFenofibrate 48 mg/1Tablet, CoatedOralNuCare Pharmaceuticals,Inc.68071-2369
FenofibrateFenofibrate 48 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-1701

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