Icosapent (icosapent ethyl) NDC 63629-9312

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-9312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-9312Add 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
63629-9312-1	63629931201	120 CAPSULE in 1 BOTTLE (63629-9312-1)Marketed from Aug 10, 2026

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
Generic name (nonproprietary): icosapent ethyl
Active ingredients: Icosapent ethyl — 1000 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209499
Marketing start: Jun 21, 2021
Marketing end: Sep 30, 2027
Identifiers: Product ID 63629-9312_9a7d5eb6-95f1-4c0e-b51f-6b79ba2e3971SPL ID 9a7d5eb6-95f1-4c0e-b51f-6b79ba2e3971SPL set ID cc28828d-beab-45cc-a3b6-151c5fee3924RxCUI 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

N463629931201 followed by a unit qualifier and the quantity

Package 63629-9312-01. 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 Aug 10, 2026.

Indications (excerpt from the label)

Icosapent ethyl capsules are indicated: as an adjunct to diet to reduce 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 TG levels in adultpatients 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)

Other NDCs under ANDA 209499

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

FDA NDC Directory listings under ANDA 209499
Product	Strength	Form · route	Labeler	Product NDC
Icosapent Ethyl	Icosapent ethyl 500 mg/1	CapsuleOral	Dr. Reddy's Laboratories, Inc.	43598-746
Icosapenticosapent ethyl	Icosapent ethyl 1000 mg/1	CapsuleOral	Dr. Reddy's Laboratories, Inc.	43598-267