Omega-3-acid ethyl esters
- Product NDC
- 63629-1918
- 11-digit product format
- 636291918
- Labeler code
- 63629
- Product ID
- 63629-1918_983c388d-45d0-446f-b12d-8fbbae69626d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207420
- Marketing category
- ANDA
- Marketing start
- 2019-02-25
- Substance
- OMEGA-3-ACID ETHYL ESTERS
- Active strength
- 1 g/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 esters
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEGA-3-ACID ETHYL ESTERS | 1 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D87YGH4Z0Q |
| Rxcui | 577208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-1918-1 | Omega-3-acid ethyl esters | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-1918 | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 1 package rows | 20241228_7d75287f-6f09-43b0-9b38-150685236d47.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-1918-1 | 63629191801 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-1918-1) | 2019-02-25 | 0000-00-00 | No | No | Current |