Omega-3-acid ethyl esters
- Product NDC
- 63629-7015
- 11-digit product format
- 636297015
- Labeler code
- 63629
- Product ID
- 63629-7015_f997ca65-ad26-48c3-97ec-18f3b2c49fa3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-7015-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2822-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP. OMEGA-3-ACID ETHYL ESTERS Capsules, USP for oral use Initial U.S. Approval: 2004 |
| 63629-7015-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2822-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP. OMEGA-3-ACID ETHYL ESTERS Capsules, USP for oral use Initial U.S. Approval: 2004 |
| 63629-7015-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2822-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP. OMEGA-3-ACID ETHYL ESTERS Capsules, USP for oral use Initial U.S. Approval: 2004 |
| 63629-7015-4 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2822-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP. OMEGA-3-ACID ETHYL ESTERS Capsules, USP for oral use Initial U.S. Approval: 2004 |
| 63629-7015-5 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2822-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP. OMEGA-3-ACID ETHYL ESTERS Capsules, USP for oral use Initial U.S. Approval: 2004 |
| 63629-7015-6 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2822-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES , USP. OMEGA-3-ACID ETHYL ESTERS Capsules, USP for oral use Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-7015-1 | Omega-3-acid ethyl esters | 90 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 90 | | 100 |
| 63629-7015-2 | Omega-3-acid ethyl esters | 28 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 28 | | 100 |
| 63629-7015-3 | Omega-3-acid ethyl esters | 60 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 60 | | 100 |
| 63629-7015-4 | Omega-3-acid ethyl esters | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 100 |
| 63629-7015-5 | Omega-3-acid ethyl esters | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | | 100 |
| 63629-7015-6 | Omega-3-acid ethyl esters | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 100 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-7015 | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] | 100 | Legacy NDC, 6 package rows | 20220624_e57f57fe-1af6-468a-9e72-d3144d63aecf.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 |
|---|
| 63629-7015-1 | 63629701501 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-7015-1) | 2022-06-22 | 0000-00-00 | No | No | Current |
| 63629-7015-2 | 63629701502 | 28 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-7015-2) | 2022-06-22 | 0000-00-00 | No | No | Current |
| 63629-7015-3 | 63629701503 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-7015-3) | 2022-06-22 | 0000-00-00 | No | No | Current |
| 63629-7015-4 | 63629701504 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-7015-4) | 2022-06-22 | 0000-00-00 | No | No | Current |
| 63629-7015-5 | 63629701505 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-7015-5) | 2022-06-22 | 0000-00-00 | No | No | Current |
| 63629-7015-6 | 63629701506 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-7015-6) | 2022-06-22 | 0000-00-00 | No | No | Current |