Prescription drug · ANDA
Omega-3-Acid Ethyl Esters NDC 51407-763
Omega-3-acid ethyl esters 1 g/1 · Capsule · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-763-12 | 51407076312 | 120 CAPSULE in 1 BOTTLE, PLASTIC (51407-763-12)Marketed from Dec 19, 2023 |
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
- Golden State Medical Supply, Inc.NDC labeler code 51407
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091028
- Marketing start
- Listing expires
- Other FDA classes
- Omega-3 (Chemical structure)
- Identifiers
- Product ID 51407-763_4ece33da-8d1d-0266-e063-6394a90ad29eSPL ID 4ece33da-8d1d-0266-e063-6394a90ad29eSPL set ID 11d744aa-cc06-1206-e063-6294a90a49c9RxCUI 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
N451407076312followed by a unit qualifier and the quantityPackage 51407-0763-12. 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 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 (HTG). Omega-3-acid ethyl esters capsules are a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (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 mortalit…
Excerpt only. Read the full label for complete information.
About NDC 51407-763
- What is NDC 51407-763?
- 51407-763 is the product NDC for Omega-3-Acid Ethyl Esters, Omega-3-acid ethyl esters 1 g/1 capsule, listed with the FDA by Golden State Medical Supply, 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?
- Golden State Medical Supply, Inc., NDC labeler code 51407. 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 | 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 | Bryant Ranch Prepack | 71335-2024 | 71335-2024-0171335-2024-0271335-2024-03+3 more |
Other NDCs under ANDA 091028
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 1 g/1 | CapsuleOral | KD Pharma USA, Inc. | 72998-851 |