Omega-3-acid ethyl esters
- Product NDC
- 60505-4462
- 11-digit product format
- 605054462
- Labeler code
- 60505
- Product ID
- 60505-4462_b6e21953-3718-143a-4134-31b2d4f19e9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA090973
- Marketing category
- ANDA
- Marketing start
- 2014-09-30
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEGA-3-ACID ETHYL ESTERS | ACTIVE INGREDIENT | D87YGH4Z0Q | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| OMEGA-3 FATTY ACIDS | ACTIVE MOIETY | 71M78END5S | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| .ALPHA.-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| Ammonia | INACTIVE INGREDIENT | 5138Q19F1X | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-4462 | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [APOTEX CORP.] | 15 | Legacy NDC | 20250523_1dd5cda1-6077-f8bc-69f3-e8685a49f39d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-4462-7 | 60505446207 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (60505-4462-7) | 2014-09-30 | 0000-00-00 | No | No | Current |