Omega-3-acid ethyl esters
- Product NDC
- 31722-936
- 11-digit product format
- 317220936
- Labeler code
- 31722
- Product ID
- 31722-936_09d3e919-e5e3-4ed5-b23c-5e91f4a95e6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- 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
- 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 |
|---|---|
| OMEGA-3-ACID ETHYL ESTERS | 1 g/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | D87YGH4Z0Q |
| Rxcui | 577208 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ef9a935e-31b7-402c-a66c-716cdfe4f126 | Product name | 9 | 20241218 |
| 115c5bd2-98e1-4a98-8292-90803ca7e851 | Product name | 1 | 20220127 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31722-936-05 | Omega-3-acid ethyl esters | 500 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 500 | 4 | |
| 31722-936-12 | Omega-3-acid ethyl esters | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 577208 | omega-3 acid ethyl esters 1 GM Oral Capsule | PSN | 7d75287f-6f09-43b0-9b38-150685236d47 | 104 |
| 577208 | omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule | SCD | 7d75287f-6f09-43b0-9b38-150685236d47 | 104 |
| 577208 | omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule | SY | 7d75287f-6f09-43b0-9b38-150685236d47 | 104 |
| 577208 | omega-3 acid ethyl esters 1 GM Oral Capsule | PSN | 034045d6-5308-4701-b97b-8873e053ec17 | 100 |
| 577208 | omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule | SCD | 034045d6-5308-4701-b97b-8873e053ec17 | 100 |
| 577208 | omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule | SY | 034045d6-5308-4701-b97b-8873e053ec17 | 100 |
| 577208 | omega-3 acid ethyl esters 1 GM Oral Capsule | PSN | 990a3e8a-8642-43d7-ace3-0dd7c48ff3e9 | 6 |
| 577208 | omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule | SCD | 990a3e8a-8642-43d7-ace3-0dd7c48ff3e9 | 6 |
| 577208 | omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule | SY | 990a3e8a-8642-43d7-ace3-0dd7c48ff3e9 | 6 |
| 577208 | omega-3 acid ethyl esters 1 GM Oral Capsule | PSN | 0d842966-26bc-4521-b401-635a83618012 | 4 |
| 577208 | omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule | SCD | 0d842966-26bc-4521-b401-635a83618012 | 4 |
| 577208 | omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule | SY | 0d842966-26bc-4521-b401-635a83618012 | 4 |
| 577208 | omega-3 acid ethyl esters 1 GM Oral Capsule | PSN | 730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa | 2 |
| 577208 | omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule | SCD | 730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa | 2 |
| 577208 | omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule | SY | 730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa | 2 |
| 577208 | omega-3 acid ethyl esters 1 GM Oral Capsule | PSN | b11807f8-4301-4f91-8a7a-53226f945c49 | 1 |
| 577208 | omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule | SCD | b11807f8-4301-4f91-8a7a-53226f945c49 | 1 |
| 577208 | omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule | SY | b11807f8-4301-4f91-8a7a-53226f945c49 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 31722-936-05 | 31722093605 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (31722-936-05) | 2019-02-25 | 0000-00-00 | No | No | Current |
| 31722-936-12 | 31722093612 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (31722-936-12) | 2019-02-25 | 0000-00-00 | No | No | Current |