Lovaza
- Product NDC
- 80725-420
- 11-digit product format
- 807250420
- Labeler code
- 80725
- Product ID
- 80725-420_bb196245-0938-40a1-bba1-c96dee9cf645
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OMEGA-3-ACID ETHYL ESTERS
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Waylis Therapeutics LLC
- Application
- NDA021654
- Marketing category
- NDA
- Marketing start
- 2025-01-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lovaza
- Listing expiration
- 2027-12-31
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, 607044 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80725-420-12 | Lovaza | 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 |
|---|
| 80725-420 | LOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE [WAYLIS THERAPEUTICS LLC] | 1 | Current NDC, 1 package rows | 20250209_21cfa4ce-0b05-47ed-b268-339eb1b83b75.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80725-420-12 | 80725042012 | 120 CAPSULE in 1 BOTTLE, PLASTIC (80725-420-12) | 120 capsule | 2025-01-15 | No | No | Current |