NDC codes

FDA NDC Directory
Product NDC (as listed)60687-764Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0764Add 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
60687-764-216068707642130 BLISTER PACK in 1 CARTON (60687-764-21) / 1 CAPSULE in 1 BLISTER PACK (60687-764-11)Marketed from Feb 21, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 1 g/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209437
Marketing start
Marketing end
Identifiers
Product ID 60687-764_47a64acc-3806-d861-e063-6394a90a8d02SPL ID 47a64acc-3806-d861-e063-6394a90a8d02SPL set ID fd28217d-5817-43b0-8185-7c7ec6da83f3RxCUI 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

N460687076421 followed by a unit qualifier and the quantity

Package 60687-0764-21. 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 .

Indications (excerpt from the label)

Icosapent ethyl capsules are indicated: as an adjunct to diet to reduce triglyceride (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 triglyceride (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 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/1CapsuleOralApotex Corp60505-4033

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