OMEGA-3-ACID ETHYL ESTERS
- Product NDC
- 71335-2024
- 11-digit product format
- 713352024
- Labeler code
- 71335
- Product ID
- 71335-2024_05917de9-e724-43c9-9cd6-2ba4753592ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OMEGA-3-ACID ETHYL ESTERS
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210093
- Marketing category
- ANDA
- Marketing start
- 2020-07-02
- 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
openFDA Listing Details
- Product ID
- 71335-2024_05917de9-e724-43c9-9cd6-2ba4753592ce
- SPL ID
- 05917de9-e724-43c9-9cd6-2ba4753592ce
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- OMEGA-3-ACID ETHYL ESTERS
- Generic name
- OMEGA-3-ACID ETHYL ESTERS
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing start
- 2020-07-02
- Marketing category
- ANDA
- Application number
- ANDA210093
- Pharmacologic classes
- Fatty Acids; Omega-3 [CS]; Omega-3 Fatty Acid [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| OMEGA-3-ACID ETHYL ESTERS | 1 g/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | D87YGH4Z0Q |
| Rxcui | 577208 |
| Spl Set Id | c8dc6c4a-ed19-4727-ba5a-35075f1ddddf |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2024-1 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-1) | 2022-01-10 | No |
| 71335-2024-2 | 28 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-2) | 2022-01-10 | No |
| 71335-2024-3 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-3) | 2022-01-10 | No |
| 71335-2024-4 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-4) | 2022-01-10 | No |
| 71335-2024-5 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-5) | 2022-01-10 | No |
| 71335-2024-6 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-6) | 2022-01-10 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| D87YGH4Z0Q | OMEGA-3-ACID ETHYL ESTERS | 308081-97-2 | OMEGA-3-ACID ETHYL ESTERS |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2024-1 | 71335202401 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-1) | 2022-01-10 | No | No | Historical |
| 71335-2024-2 | 71335202402 | 28 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-2) | 2022-01-10 | No | No | Historical |
| 71335-2024-3 | 71335202403 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-3) | 2022-01-10 | No | No | Historical |
| 71335-2024-4 | 71335202404 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-4) | 2022-01-10 | No | No | Historical |
| 71335-2024-5 | 71335202405 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-5) | 2022-01-10 | No | No | Historical |
| 71335-2024-6 | 71335202406 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2024-6) | 2022-01-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| OMEGA-3-ACID ETHYL ESTERS | Bryant Ranch Prepack | 2024-08-08 | HUMAN PRESCRIPTION DRUG LABEL | 103 |