Icosapent Ethyl NDC 0480-0126

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-0126Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-0126Add 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
0480-0126-49	00480012649	240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0126-49)Marketed from Sep 9, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 500 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Teva Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209525
Marketing start: Sep 9, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 0480-0126_3a46b5b6-c6c0-40b7-b3d2-dd1b9da9ca30SPL ID 3a46b5b6-c6c0-40b7-b3d2-dd1b9da9ca30SPL set ID de7049ae-d1d6-4267-a93b-dd5039c50c2cRxCUI 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

N400480012649 followed by a unit qualifier and the quantity

Package 00480-0126-49. 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 27, 2021.

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 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)

Other NDCs under ANDA 209525

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

FDA NDC Directory listings under ANDA 209525
Product	Strength	Form · route	Labeler	Product NDC
Icosapent Ethyl	Icosapent ethyl 1 g/1	Capsule, Liquid filledOral	Teva Pharmaceuticals, Inc.	0480-0127