NDC codes

FDA NDC Directory
Product NDC (as listed)62135-894Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0894Add 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
62135-894-906213508949090 CAPSULE in 1 BOTTLE (62135-894-90)Marketed from Sep 12, 2024

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 — 134 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Chartwell RX, LLC.NDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211407
Marketing start
Listing expires
Identifiers
Product ID 62135-894_459be037-d59a-9ee0-e063-6394a90a3b5eSPL ID 459be037-d59a-9ee0-e063-6394a90a3b5eSPL set ID 2d0cfddc-ace3-4187-8d94-d760d23d20b6RxCUI 200311, 310288, 310289UNII U202363UOSUPC 0362135899905, 0362135894900, 0362135893903
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

N462135089490 followed by a unit qualifier and the quantity

Package 62135-0894-90. 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)

INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-894

What is NDC 62135-894?
62135-894 is the product NDC for fenofibrate, Fenofibrate 134 mg/1 capsule, listed with the FDA by Chartwell RX, 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?
Chartwell RX, LLC., NDC labeler code 62135. 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 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 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 211407

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

FDA NDC Directory listings under ANDA 211407
ProductStrengthForm · routeLabelerProduct NDC
fenofibrateFenofibrate 67 mg/1CapsuleOralChartwell RX, LLC.62135-893
fenofibrateFenofibrate 200 mg/1CapsuleOralChartwell RX, LLC.62135-899

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