Prescription drug · ANDA
Omega-3-Acid Ethyl Ester (Omega-3-acid ethyl esters) NDC 69452-175
Omega-3-acid ethyl esters 900 mg/1 · Capsule, Liquid filled · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-175-17 | 69452017517 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-17)Marketed from Jan 15, 2017 | |
| 69452-175-22 | 69452017522 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-22)Marketed from Jan 15, 2017 |
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 Ester
- Generic name (nonproprietary)
- omega-3-acid ethyl esters
- Active ingredients
- Omega-3-acid ethyl esters — 900 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206455
- Marketing start
- Listing expires
- Other FDA classes
- Omega-3 (Chemical structure)
- Identifiers
- Product ID 69452-175_c1aebacc-8c18-3f0d-e053-2a95a90ab85aSPL ID c1aebacc-8c18-3f0d-e053-2a95a90ab85aSPL set ID 91ef2e89-e816-4494-9558-2f647b7452f8RxCUI 577208UNII D87YGH4Z0QUPC 0369452175224
- 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
N469452017517followed by a unit qualifier and the quantityPackage 69452-0175-17. 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/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 capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients,…
Excerpt only. Read the full label for complete information.
About NDC 69452-175
- What is NDC 69452-175?
- 69452-175 is the product NDC for Omega-3-Acid Ethyl Ester (omega-3-acid ethyl esters), Omega-3-acid ethyl esters 900 mg/1 capsule, liquid filled, listed with the FDA by Bionpharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omega-3-Acid Ethyl Ester (Omega-3-acid ethyl esters).
- What is the active ingredient?
- Omega-3-acid ethyl esters.
- Who is the labeler?
- Bionpharma Inc., NDC labeler code 69452. 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 Ester?
- 1 other product NDC are listed under this name. See all Omega-3-Acid Ethyl Ester 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 Ester 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 Esteromega-3-acid ethyl esters | Omega-3-acid ethyl esters 900 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 63629-2448 | 63629-2448-01 |
Other NDCs under ANDA 206455
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 Esteromega-3-acid ethyl esters | Omega-3-acid ethyl esters 900 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 63629-2448 |