NDC codes

FDA NDC Directory
Product NDC (as listed)70710-1592Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70710-1592Add 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 NDC11-digit (billing)PackageCopy
70710-1592-77071015920770710159207120 CAPSULE in 1 BOTTLE (70710-1592-7)Marketed from Aug 4, 2023

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
Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217656
Marketing start
Listing expires
Identifiers
Product ID 70710-1592_fc13bee2-0828-4bc5-b967-b47e368f0a24SPL ID fc13bee2-0828-4bc5-b967-b47e368f0a24SPL set ID 5910742b-c5e6-4029-9a19-97669e3808bcRxCUI 1304979, 1811180UNII 6GC8A4PAYHUPC 0370710159276

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

N470710159207 followed by a unit qualifier and the quantity

Package 70710-1592-07. 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 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 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)

About NDC 70710-1592

What is NDC 70710-1592?
70710-1592 is the product NDC for icosapent ethyl, Icosapent ethyl 1 g/1 capsule, listed with the FDA by Zydus Pharmaceuticals USA Inc.. 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Icosapent ethylIcosapent ethyl 1 g/1CapsuleOralAurobindo Pharma Limited59651-81259651-0812-08
Icosapent Ethylicosapent ethyl capsulesIcosapent ethyl 1 g/gCapsule, Liquid filledOralTorrent Pharmaceuticals Limited13668-76113668-0761-12
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralVitruvias Therapeutics, Inc.69680-18669680-0186-92
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralNorthstar Rx LLC16714-63616714-0636-01
icosapent ethylIcosapent ethyl 1 g/1CapsuleOralSoftgel Healthcare Private Limited35916-159235916-1592-01
icosapent ethylIcosapent ethyl .5 g/1CapsuleOralSoftgel Healthcare Private Limited35916-173835916-1738-01
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralQilu Pharmaceutical Co., Ltd.67184-058267184-0582-01
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralAmerican Health Packaging60687-76460687-0764-21
Icosapent EthylIcosapent ethyl .5 g/1CapsuleOralCamber Pharmaceuticals, Inc.31722-29831722-0298-24
Icosapent EthylIcosapent ethyl 1 g/1CapsuleOralCamber Pharmaceuticals, Inc.31722-29931722-0299-12

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
ProductStrengthForm · routeLabelerProduct NDC
icosapent ethylIcosapent ethyl 1 g/1CapsuleOralSoftgel Healthcare Private Limited35916-1592
icosapent ethylIcosapent ethyl .5 g/1CapsuleOralSoftgel Healthcare Private Limited35916-1738
icosapent ethylIcosapent ethyl .5 g/1CapsuleOralZydus Pharmaceuticals USA Inc.70710-1738

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