LOVAZA
- Product NDC
- 0173-0884
- 11-digit product format
- 001730884
- Labeler code
- 0173
- Product ID
- 0173-0884_e4239cb8-fd3c-41bd-96e5-20ecfe426351
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- GlaxoSmithKline LLC
- Application
- NDA021654
- Marketing category
- NDA
- Marketing start
- 2016-05-19
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ef9a935e-31b7-402c-a66c-716cdfe4f126 | Product name | 9 | 20241218 |
| 115c5bd2-98e1-4a98-8292-90803ca7e851 | Product name | 1 | 20220127 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0173-0884-08 | EA - Each | 0173-0884 | 1a71897b-dfcd-480a-abee-01c07b527c5f | 1 | 2016-06-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 607044 | Lovaza 1 GM Oral Capsule | PSN | 56fa49bf-ee99-4152-aa21-072128738afb | 2 |
| 577208 | omega-3 acid ethyl esters 1 GM Oral Capsule | PSN | 56fa49bf-ee99-4152-aa21-072128738afb | 2 |
| 607044 | omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [Lovaza] | SBD | 56fa49bf-ee99-4152-aa21-072128738afb | 2 |
| 577208 | omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule | SCD | 56fa49bf-ee99-4152-aa21-072128738afb | 2 |
| 607044 | Lovaza 1000 MG (at least 900 MG) Oral Capsule | SY | 56fa49bf-ee99-4152-aa21-072128738afb | 2 |
| 607044 | Omacor 1 GM Oral Capsule | SY | 56fa49bf-ee99-4152-aa21-072128738afb | 2 |
| 577208 | omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule | SY | 56fa49bf-ee99-4152-aa21-072128738afb | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0173-0884-08 | 00173088408 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0173-0884-08) | 2016-05-19 | 0000-00-00 | No | No | Current |