Prescription drug · ANDA
Omega-3-acid ethyl esters NDC 0254-3010
Omega-3-acid ethyl esters 900 mg/1 · Capsule · Oral · Par Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0254-3010-08 | 00254301008 | 120 CAPSULE in 1 BOTTLE (0254-3010-08)Marketed from Sep 19, 2017 |
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)
- Omega-3-acid ethyl esters
- Generic name (nonproprietary)
- omega-3-acid ethyl esters
- Active ingredients
- Omega-3-acid ethyl esters — 900 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Par Pharmaceutical Inc.NDC labeler code 0254
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203893
- Marketing start
- Listing expires
- Other FDA classes
- Omega-3 (Chemical structure)
- Identifiers
- Product ID 0254-3010_9b349968-03b7-4a4f-ab40-976570f5e398SPL ID 9b349968-03b7-4a4f-ab40-976570f5e398SPL set ID b53f1c14-43da-4e05-8c80-a0a455dd41cfRxCUI 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
N400254301008followed by a unit qualifier and the quantityPackage 00254-3010-08. 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 capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control…
Excerpt only. Read the full label for complete information.
About NDC 0254-3010
- What is NDC 0254-3010?
- 0254-3010 is the product NDC for Omega-3-acid ethyl esters, Omega-3-acid ethyl esters 900 mg/1 capsule, listed with the FDA by Par Pharmaceutical 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?
- Par Pharmaceutical Inc., NDC labeler code 0254. 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.
Related NDCs: other Omega-3-acid ethyl esters products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Omega-3-acid ethyl esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | REMEDYREPACK INC. | 70518-4744 | 70518-4744-00 |
| omega-3-acid ethyl esters | Omega-3-acid ethyl esters 900 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-761 | 64380-0761-0264380-0761-11 |
| omega-3-acid ethyl esters | Omega-3-acid ethyl esters 900 mg/1 | CapsuleOral | American Health Packaging | 60687-846 | 60687-0846-65 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | Major Pharmaceuticals | 0904-7495 | 00904-7495-06 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | CapsuleOral | KD Pharma USA, Inc. | 72998-851 | 72998-0851-12 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | Lifestar Pharma LLC | 70756-423 | 70756-0423-22 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | CapsuleOral | KD Pharma USA, Inc. | 72998-850 | 72998-0850-12 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | REMEDYREPACK INC. | 70518-3040 | 70518-3040-0070518-3040-01 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8550 | 00615-8550-39 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-350 | 24658-0350-12 |
Other NDCs under ANDA 203893
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| omega-3-acid ethyl esters | Omega-3-acid ethyl esters 900 mg/1 | CapsuleOral | American Health Packaging | 60687-846 |
| omega-3-acid ethyl esters | Omega-3-acid ethyl esters 900 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-761 |