Omega-3-acid ethyl esters
- Product NDC
- 72865-139
- 11-digit product format
- 728650139
- Labeler code
- 72865
- Product ID
- 72865-139_b1d36d46-9e6f-4d12-abe1-d47abe02ad5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals, Inc.
- Application
- ANDA207420
- Marketing category
- ANDA
- Marketing start
- 2020-02-17
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omega-3-acid ethyl esters
- Listing expiration
- 2027-12-31
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 |
|---|
| 72865-139-05 | Omega-3-acid ethyl esters | 500 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 500 | | 4 |
| 72865-139-12 | Omega-3-acid ethyl esters | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-139 | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [XLCARE PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20210729_18947318-31b4-42fb-83be-8f1bfe732e95.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 |
|---|
| 72865-139-05 | 72865013905 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-05) | 2020-02-17 | 0000-00-00 | No | No | Current |
| 72865-139-12 | 72865013912 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-139-12) | 2020-02-17 | 0000-00-00 | No | No | Current |