NDC codes

FDA NDC Directory
Product NDC (as listed)72998-850Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72998-0850Add 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
72998-850-1272998085012120 CAPSULE in 1 BOTTLE, PLASTIC (72998-850-12)Marketed from May 1, 2021

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)
Omega-3-Acid Ethyl Esters
Generic name (nonproprietary)
omega-3-acid ethyl esters
Active ingredients
Omega-3-acid ethyl esters — 1 g/1
Dosage form
Capsule
Route
Oral
Labeler
KD Pharma USA, Inc.NDC labeler code 72998
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212504
Marketing start
Listing expires
Other FDA classes
Omega-3 (Chemical structure)
Identifiers
Product ID 72998-850_c51df0eb-53aa-40b8-974d-127c0c8a0be0SPL ID c51df0eb-53aa-40b8-974d-127c0c8a0be0SPL set ID 5cf3091e-4a88-4799-a88a-d53a5bc1de57RxCUI 577208UNII D87YGH4Z0Q
Pharmacologic class
Omega-3 Fatty Acid

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

N472998085012 followed by a unit qualifier and the quantity

Package 72998-0850-12. 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)

Omega-3-acid ethyl esters is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Omega-3-acid ethyl esters are a combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). ( 1 ) Limitations of Use: The effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. ( 1 ) The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined. ( 1 ) Usage Consideration…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72998-850

What is NDC 72998-850?
72998-850 is the product NDC for Omega-3-Acid Ethyl Esters, Omega-3-acid ethyl esters 1 g/1 capsule, listed with the FDA by KD Pharma USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Omega-3-Acid Ethyl Esters.
What is the active ingredient?
Omega-3-acid ethyl esters.
Who is the labeler?
KD Pharma USA, Inc., NDC labeler code 72998. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Omega-3-Acid Ethyl Esters?
23 other product NDCs are listed under this name. See all Omega-3-Acid Ethyl Esters 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 Omega-3-Acid Ethyl Esters NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Omega-3-acid ethyl estersOmega-3-acid ethyl esters 1 g/1Capsule, Liquid filledOralREMEDYREPACK INC.70518-474470518-4744-00
omega-3-acid ethyl estersOmega-3-acid ethyl esters 900 mg/1CapsuleOralStrides Pharma Science Limited64380-76164380-0761-0264380-0761-11
omega-3-acid ethyl estersOmega-3-acid ethyl esters 900 mg/1CapsuleOralAmerican Health Packaging60687-84660687-0846-65
Omega-3-Acid Ethyl EstersOmega-3-acid ethyl esters 1 g/1Capsule, Liquid filledOralMajor Pharmaceuticals0904-749500904-7495-06
Omega-3-Acid Ethyl EstersOmega-3-acid ethyl esters 1 g/1CapsuleOralKD Pharma USA, Inc.72998-85172998-0851-12
Omega-3-Acid Ethyl EstersOmega-3-acid ethyl esters 1 g/1Capsule, Liquid filledOralLifestar Pharma LLC70756-42370756-0423-22
Omega-3-Acid Ethyl EstersOmega-3-acid ethyl esters 1 g/1Capsule, Liquid filledOralREMEDYREPACK INC.70518-304070518-3040-0070518-3040-01
Omega-3-Acid Ethyl EstersOmega-3-acid ethyl esters 1 g/1Capsule, Liquid filledOralNCS HealthCare of KY, LLC dba Vangard Labs0615-855000615-8550-39
Omega-3-Acid Ethyl EstersOmega-3-acid ethyl esters 1 g/1Capsule, Liquid filledOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-35024658-0350-12
Omega-3-Acid Ethyl EstersOmega-3-acid ethyl esters 1 g/1Capsule, Liquid filledOralEPIC PHARMA, LLC42806-55242806-0552-12

All 24 Omega-3-Acid Ethyl Esters NDCs

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Omega-3-Acid Ethyl Esters NDC 72998-850 | Med-Code