NDC codes

FDA NDC Directory
Product NDC (as listed)67184-0582Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67184-0582Add 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
67184-0582-16718405820167184058201120 CAPSULE in 1 BOTTLE (67184-0582-1)Marketed from Jan 1, 2025

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)
Icosapent Ethyl
Generic name (nonproprietary)
icosapent ethyl
Active ingredients
Icosapent ethyl — 1 g/1
Dosage form
Capsule
Route
Oral
Labeler
Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218899
Marketing start
Listing expires
Identifiers
Product ID 67184-0582_324fd508-befc-404a-8f75-97b35d2df694SPL ID 324fd508-befc-404a-8f75-97b35d2df694SPL set ID 20686acb-66c5-4d75-9684-7474436e8befRxCUI 1304979UNII 6GC8A4PAYH

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

N467184058201 followed by a unit qualifier and the quantity

Package 67184-0582-01. 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)

Icosapent ethyl capsules are indicated: • as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) indicated: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. ( 1 ) Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. ( 1 )…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67184-0582

What is NDC 67184-0582?
67184-0582 is the product NDC for Icosapent Ethyl, Icosapent ethyl 1 g/1 capsule, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Icosapent Ethyl.
What is the active ingredient?
Icosapent ethyl.
Who is the labeler?
Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Icosapent Ethyl?
32 other product NDCs are listed under this name. See all Icosapent Ethyl 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 Icosapent Ethyl NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Icosapent ethylIcosapent ethyl 1 g/1CapsuleOralAurobindo Pharma Limited59651-81259651-0812-08
Icosapent Ethylicosapent ethyl capsulesIcosapent ethyl 1 g/gCapsule, Liquid filledOralTorrent Pharmaceuticals Limited13668-76113668-0761-12
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralVitruvias Therapeutics, Inc.69680-18669680-0186-92
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralNorthstar Rx LLC16714-63616714-0636-01
icosapent ethylIcosapent ethyl 1 g/1CapsuleOralSoftgel Healthcare Private Limited35916-159235916-1592-01
icosapent ethylIcosapent ethyl .5 g/1CapsuleOralSoftgel Healthcare Private Limited35916-173835916-1738-01
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralAmerican Health Packaging60687-76460687-0764-21
Icosapent EthylIcosapent ethyl .5 g/1CapsuleOralCamber Pharmaceuticals, Inc.31722-29831722-0298-24
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralCamber Pharmaceuticals, Inc.31722-29931722-0299-12
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralBryant Ranch Prepack71335-298971335-2989-0171335-2989-0271335-2989-03+1 more

All 33 Icosapent Ethyl NDCs

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