What is NDC 35916-1592?

35916-1592 is the product NDC for icosapent ethyl, Icosapent ethyl 1 g/1 capsule, listed with the FDA by Softgel Healthcare Private Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Softgel Healthcare Private Limited, NDC labeler code 35916. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

icosapent ethyl NDC 35916-1592 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)35916-1592Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35916-1592Add 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 NDC	11-digit (billing)	Package	Copy
35916-1592-1	3591615920135916159201	120 CAPSULE in 1 BOTTLE (35916-1592-1)Marketed from Mar 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: Softgel Healthcare Private LimitedNDC labeler code 35916
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217656
Marketing start: Mar 1, 2025
Listing expires: Dec 31, 2027
Identifiers: Product ID 35916-1592_dc378404-3406-4fc0-829d-cc8273af1ca0SPL ID dc378404-3406-4fc0-829d-cc8273af1ca0SPL set ID 6f5838cd-4d17-401d-8e2a-652d0e73c1e9RxCUI 1304979, 1811180UNII 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

N435916159201 followed by a unit qualifier and the quantity

Package 35916-1592-01. 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 Jul 9, 2026.

Full label on DailyMed (opens in a new tab)

About NDC 35916-1592

What is NDC 35916-1592?: 35916-1592 is the product NDC for icosapent ethyl, Icosapent ethyl 1 g/1 capsule, listed with the FDA by Softgel Healthcare Private Limited. 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?: Softgel Healthcare Private Limited, NDC labeler code 35916. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Icosapent ethyl	Icosapent ethyl 1 g/1	CapsuleOral	Aurobindo Pharma Limited	59651-812	59651-0812-08
Icosapent Ethylicosapent ethyl capsules	Icosapent ethyl 1 g/g	Capsule, Liquid filledOral	Torrent Pharmaceuticals Limited	13668-761	13668-0761-12
Icosapent Ethyl	Icosapent ethyl 1 g/1	CapsuleOral	Vitruvias Therapeutics, Inc.	69680-186	69680-0186-92
Icosapent Ethyl	Icosapent ethyl 1 g/1	CapsuleOral	Northstar Rx LLC	16714-636	16714-0636-01
icosapent ethyl	Icosapent ethyl .5 g/1	CapsuleOral	Softgel Healthcare Private Limited	35916-1738	35916-1738-01
Icosapent Ethyl	Icosapent ethyl 1 g/1	CapsuleOral	Qilu Pharmaceutical Co., Ltd.	67184-0582	67184-0582-01
Icosapent Ethyl	Icosapent ethyl 1 g/1	CapsuleOral	American Health Packaging	60687-764	60687-0764-21
Icosapent Ethyl	Icosapent ethyl .5 g/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-298	31722-0298-24
Icosapent Ethyl	Icosapent ethyl 1 g/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-299	31722-0299-12
Icosapent Ethyl	Icosapent ethyl 1 g/1	CapsuleOral	Bryant Ranch Prepack	71335-2989	71335-2989-0171335-2989-0271335-2989-03+1 more

All 33 icosapent ethyl NDCs

Other NDCs under ANDA 217656

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

FDA NDC Directory listings under ANDA 217656
Product	Strength	Form · route	Labeler	Product NDC
icosapent ethyl	Icosapent ethyl .5 g/1	CapsuleOral	Softgel Healthcare Private Limited	35916-1738
icosapent ethyl	Icosapent ethyl 1 g/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1592
icosapent ethyl	Icosapent ethyl .5 g/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1738