omega-3-acid ethyl esters
- Product NDC
- 62135-780
- 11-digit product format
- 621350780
- Labeler code
- 62135
- Product ID
- 62135-780_46879b05-8040-8318-e063-6294a90ad8cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA211355
- Marketing category
- ANDA
- Marketing start
- 2020-02-19
- Substance
- OMEGA-3-ACID ETHYL ESTERS
- Active strength
- 900 mg/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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- omega-3-acid ethyl esters
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEGA-3-ACID ETHYL ESTERS | 900 mg/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 |
|---|
| 62135-780-12 | omega-3-acid ethyl esters | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-780 | OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [CHARTWELL RX, LLC] | 4 | Current NDC, 1 package rows | 20241025_331d5d9d-58d8-4b4f-8114-b28efa7276d7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-780-12 | 62135078012 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (62135-780-12) | 2023-10-10 | No | No | Current |