Prescription drug · ANDA
Omega-3-Acid Ethyl Ester (Omega-3-acid ethyl esters) NDC 63629-2448
Omega-3-acid ethyl esters 900 mg/1 · Capsule, Liquid filled · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2448-1 | 63629244801 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-2448-1)Marketed from Nov 10, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-2448_1f7ec163-5055-457e-b725-1c1af6aa7d9dSPL ID 1f7ec163-5055-457e-b725-1c1af6aa7d9dSPL set ID 09ce03c0-1c22-4c60-a532-f781949f3172UNII 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
N463629244801followed by a unit qualifier and the quantityPackage 63629-2448-01. 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 63629-2448
- What is NDC 63629-2448?
- 63629-2448 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 Bryant Ranch Prepack. It has 1 package NDC, 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 | Bionpharma Inc. | 69452-175 | 69452-0175-1769452-0175-22 |
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 | Bionpharma Inc. | 69452-175 |