NDC codes

FDA NDC Directory
Product NDC (as listed)69367-254Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69367-0254Add 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
69367-254-09693670254096936702540990 TABLET, FILM COATED in 1 BOTTLE (69367-254-09)Marketed from Apr 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 — 160 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Westminster Pharmaceuticals, LLCNDC labeler code 69367
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207803
Marketing start
Listing expires
Identifiers
Product ID 69367-254_fe2bd46a-a8e7-4ec7-94cb-4d43c5d4b23fSPL ID fe2bd46a-a8e7-4ec7-94cb-4d43c5d4b23f
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

N469367025409 followed by a unit qualifier and the quantity

Package 69367-0254-09. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 69367-254

What is NDC 69367-254?
69367-254 is the product NDC for Fenofibrate, Fenofibrate 160 mg/1 tablet, film coated, listed with the FDA by Westminster Pharmaceuticals, 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?
Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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 207803

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

FDA NDC Directory listings under ANDA 207803
ProductStrengthForm · routeLabelerProduct NDC
FenofibrateFenofibrate 54 mg/1Tablet, Film coatedOralBostal LLC35561-343
FenofibrateFenofibrate 160 mg/1Tablet, Film coatedOralBostal LLC35561-344
FenofibrateFenofibrate 160 mg/1Tablet, Film coatedOralAvKARE42291-427
FenofibrateFenofibrate 160 mg/1Tablet, Film coatedOralProficient Rx LP71205-949

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