icosapent ethyl NDC 35916-1592

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	35916159201	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 Limited
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)

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	Zydus Pharmaceuticals USA Inc.	70710-1738
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