Omega-3-Acid Ethyl Ester
- Product NDC
- 63629-2448
- 11-digit product format
- 636292448
- Labeler code
- 63629
- Product ID
- 63629-2448_1f7ec163-5055-457e-b725-1c1af6aa7d9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA206455
- Marketing category
- ANDA
- Marketing start
- 2017-01-15
- Substance
- OMEGA-3-ACID ETHYL ESTERS
- Active strength
- 900 mg/1
- Pharmacologic classes
- Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omega-3-Acid Ethyl Ester
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEGA-3-ACID ETHYL ESTERS | 900 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D87YGH4Z0Q |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-2448-1 | 63629244801 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-2448-1) | 2021-11-10 | 0000-00-00 | No | No | Current |