NDC codes

FDA NDC Directory
Product NDC (as listed)62332-350Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0350Add 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
62332-350-306233203503030 TABLET, FILM COATED in 1 BOTTLE (62332-350-30)Marketed from Jan 23, 2020
62332-350-7162332035071500 TABLET, FILM COATED in 1 BOTTLE (62332-350-71)Marketed from Jan 23, 2020
62332-350-906233203509090 TABLET, FILM COATED in 1 BOTTLE (62332-350-90)Marketed from Jan 23, 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, Film coated
Route
Oral
Labeler
Alembic Pharmaceuticals Inc.NDC labeler code 62332
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213252
Marketing start
Listing expires
Identifiers
Product ID 62332-350_1b98883d-5552-4efa-9201-da42ea253aaeSPL ID 1b98883d-5552-4efa-9201-da42ea253aaeSPL set ID 1e56492f-e2b1-4a07-b697-b59b3a0ac05eRxCUI 349287, 351133UNII U202363UOSUPC 0362332351305, 0362332350308
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

N462332035030 followed by a unit qualifier and the quantity

Package 62332-0350-30. 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 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 tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62332-350

What is NDC 62332-350?
62332-350 is the product NDC for Fenofibrate, Fenofibrate 54 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 3 package NDCs, 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?
Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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 ANDA 213252

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

FDA NDC Directory listings under ANDA 213252
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 54 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-350
FenofibrateFenofibrate 160 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-351
FenofibrateFenofibrate 160 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-351

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