Omtryg
- Product NDC
- 61112-001
- 11-digit product format
- 611120001
- Labeler code
- 61112
- Product ID
- 61112-001_6d0147c3-27c1-4737-8a76-edd4c8f01ca6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omega-3-acid ethyl esters
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Trygg Pharma Inc
- Application
- NDA204977
- Marketing category
- NDA
- Marketing start
- 2016-07-01
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61112-001-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1f3f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OMTRYG™ safely and effectively. See full prescribing information for OMTRYG. OMTRYG (omega-3-acid ethyl esters) capsules, USP, for oral use Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61112-001-01 | Omtryg | 120 in 1 BOTTLE | CAPSULE | 120 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OMEGA-3-ACID ETHYL ESTERS | ACTIVE INGREDIENT | D87YGH4Z0Q | OMTRYG (OMEGA-3-ACID ETHYL ESTERS A) CAPSULE [TRYGG PHARMA INC] | 2 | |
| OMEGA-3 FATTY ACIDS | ACTIVE MOIETY | 71M78END5S | OMTRYG (OMEGA-3-ACID ETHYL ESTERS A) CAPSULE [TRYGG PHARMA INC] | 2 | |
| .ALPHA.-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | OMTRYG (OMEGA-3-ACID ETHYL ESTERS A) CAPSULE [TRYGG PHARMA INC] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMTRYG (OMEGA-3-ACID ETHYL ESTERS A) CAPSULE [TRYGG PHARMA INC] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | OMTRYG (OMEGA-3-ACID ETHYL ESTERS A) CAPSULE [TRYGG PHARMA INC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OMTRYG (OMEGA-3-ACID ETHYL ESTERS A) CAPSULE [TRYGG PHARMA INC] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1539373 | omega-3 acid ethyl esters 1.2 GM Oral Capsule | PSN | 5fe15bdb-f59f-4b87-8e5d-8a3d5683eb3d | 3 |
| 1539691 | Omtryg 1.2 GM Oral Capsule | PSN | 5fe15bdb-f59f-4b87-8e5d-8a3d5683eb3d | 3 |
| 1539691 | omega-3 acid ethyl esters (USP) 1200 MG Oral Capsule [Omtryg] | SBD | 5fe15bdb-f59f-4b87-8e5d-8a3d5683eb3d | 3 |
| 1539373 | omega-3 acid ethyl esters (USP) 1200 MG Oral Capsule | SCD | 5fe15bdb-f59f-4b87-8e5d-8a3d5683eb3d | 3 |
| 1539373 | omega-3 acid ethyl esters 1.2 GM Oral Capsule | SY | 5fe15bdb-f59f-4b87-8e5d-8a3d5683eb3d | 3 |
| 1539691 | Omtryg 1.2 GM Oral Capsule | SY | 5fe15bdb-f59f-4b87-8e5d-8a3d5683eb3d | 3 |
| 1539691 | Omtryg 1200 MG Oral Capsule | SY | 5fe15bdb-f59f-4b87-8e5d-8a3d5683eb3d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 61112-001-01 | 61112000101 | 120 in 1 BOTTLE | Historical |