NDC codes

FDA NDC Directory
Product NDC (as listed)60505-4033Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-4033Add 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
60505-4033-16050540330160505403301120 CAPSULE in 1 BOTTLE (60505-4033-1)Marketed from Dec 16, 2021

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
Apotex CorpNDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209437
Marketing start
Marketing end
Identifiers
Product ID 60505-4033_131d2bd6-c27a-36af-da0f-2102b32e1e06SPL ID 131d2bd6-c27a-36af-da0f-2102b32e1e06

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

N460505403301 followed by a unit qualifier and the quantity

Package 60505-4033-01. 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

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

About NDC 60505-4033

What is NDC 60505-4033?
60505-4033 is the product NDC for Icosapent Ethyl, Icosapent ethyl 1 g/1 capsule, listed with the FDA by Apotex Corp. 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?
Apotex Corp, NDC labeler code 60505. 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/1CapsuleOralQilu Pharmaceutical Co., Ltd.67184-058267184-0582-01
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

All 33 Icosapent Ethyl NDCs

Other NDCs under ANDA 209437

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

FDA NDC Directory listings under ANDA 209437
ProductStrengthForm · routeLabelerProduct NDC
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralGolden State Medical Supply, Inc.60429-005
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralAmerican Health Packaging60687-764

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