Prescription drug · ANDA
omega-3-acid ethyl esters NDC 64380-761
Omega-3-acid ethyl esters 900 mg/1 · Capsule · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-761-02 | 64380076102 | 5 BLISTER PACK in 1 CARTON (64380-761-02) / 10 CAPSULE in 1 BLISTER PACK (64380-761-01)Marketed from May 29, 2026 | |
| 64380-761-11 | 64380076111 | 120 CAPSULE in 1 BOTTLE (64380-761-11)Marketed from May 29, 2026 |
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 — 900 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- 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 64380-761_5a7c1a6b-2fe6-44c6-e063-6394a90aedeaSPL ID 5a7c1a6b-2fe6-44c6-e063-6394a90aedeaSPL set ID 9499c40e-6665-4fbf-914d-1a9931b93562RxCUI 577208UNII D87YGH4Z0QUPC 0364380761112
- 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
N464380076102followed by a unit qualifier and the quantityPackage 64380-0761-02. 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, are 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. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. 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…
Excerpt only. Read the full label for complete information.
About NDC 64380-761
- What is NDC 64380-761?
- 64380-761 is the product NDC for omega-3-acid ethyl esters, Omega-3-acid ethyl esters 900 mg/1 capsule, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, 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?
- Strides Pharma Science Limited, NDC labeler code 64380. 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 | 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 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | EPIC PHARMA, LLC | 42806-552 | 42806-0552-12 |
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 | Par Pharmaceutical Inc. | 0254-3010 |