NDC codes

FDA NDC Directory
Product NDC (as listed)62332-361Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0361Add 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
62332-361-306233203613030 TABLET, FILM COATED in 1 BOTTLE (62332-361-30)Marketed from Aug 9, 2019
62332-361-7162332036171500 TABLET, FILM COATED in 1 BOTTLE (62332-361-71)Marketed from Aug 9, 2019
62332-361-906233203619090 TABLET, FILM COATED in 1 BOTTLE (62332-361-90)Marketed from Aug 9, 2019

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 — 145 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210476
Marketing start
Listing expires
Identifiers
Product ID 62332-361_69d8eb8b-074c-4209-8bbd-ac35b1364d15SPL ID 69d8eb8b-074c-4209-8bbd-ac35b1364d15SPL set ID 5c579378-e00e-4802-b9d3-c062cf8bd9f4RxCUI 477560, 477562UNII U202363UOSUPC 0362332360307, 0362332361304
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

N462332036130 followed by a unit qualifier and the quantity

Package 62332-0361-30. 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 is 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210476

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

FDA NDC Directory listings under ANDA 210476
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 145 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-361
FenofibrateFenofibrate 48 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-360
FenofibrateFenofibrate 48 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-360

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