OMEGA-3-ACID ETHYL ESTERS
- Product NDC
- 72998-850
- 11-digit product format
- 729980850
- Labeler code
- 72998
- Product ID
- 72998-850_c51df0eb-53aa-40b8-974d-127c0c8a0be0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OMEGA-3-ACID ETHYL ESTERS
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- KD Pharma USA, Inc.
- Application
- ANDA212504
- Marketing category
- ANDA
- Marketing start
- 2021-05-01
- 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
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 | 1 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D87YGH4Z0Q |
| Rxcui | 577208 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72998-850-12 | OMEGA-3-ACID ETHYL ESTERS | 120 in 1 BOTTLE, PLASTIC | CAPSULE | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72998-850 | OMEGA-3-ACID ETHYL ESTERS CAPSULE [KD PHARMA USA, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250213_5cf3091e-4a88-4799-a88a-d53a5bc1de57.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72998-850-12 | 72998085012 | 120 CAPSULE in 1 BOTTLE, PLASTIC (72998-850-12) | 120 capsule | 2021-05-01 | 0000-00-00 | No | No | Current |