FDA.reportPublic FDA data

LOVAZA

Product NDC
0173-0783
11-digit product format
001730783
Labeler code
0173
Product ID
0173-0783_6ef30e20-23d5-4c2c-a306-19ee5ff63d71
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
2008-10-21
Marketing end
2019-10-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0783-02EA - Each0173-0783594e87ef-9026-4b96-84ee-74cd2b05a37412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEGA-3-ACID ETHYL ESTERSACTIVE INGREDIENTD87YGH4Z0QLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
OMEGA-3-ACID ETHYL ESTERSACTIVE MOIETYD87YGH4Z0QLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1LOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
OMEGA-3-ACID ETHYL ESTERSACTIVE INGREDIENTD87YGH4Z0QLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]1
OMEGA-3-ACID ETHYL ESTERSACTIVE MOIETYD87YGH4Z0QLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1LOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607044Lovaza 1 GM Oral CapsulePSNe8adf027-a288-43bf-961d-088fe10280473
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNe8adf027-a288-43bf-961d-088fe10280473
607044omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [Lovaza]SBDe8adf027-a288-43bf-961d-088fe10280473
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDe8adf027-a288-43bf-961d-088fe10280473
607044Lovaza 1000 MG (at least 900 MG) Oral CapsuleSYe8adf027-a288-43bf-961d-088fe10280473
607044Omacor 1 GM Oral CapsuleSYe8adf027-a288-43bf-961d-088fe10280473
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYe8adf027-a288-43bf-961d-088fe10280473
607044Lovaza 1 GM Oral CapsulePSNfb2141cd-6cff-470c-b776-4482afcebb412
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNfb2141cd-6cff-470c-b776-4482afcebb412
607044omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [Lovaza]SBDfb2141cd-6cff-470c-b776-4482afcebb412
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDfb2141cd-6cff-470c-b776-4482afcebb412
607044Lovaza 1000 MG (at least 900 MG) Oral CapsuleSYfb2141cd-6cff-470c-b776-4482afcebb412
607044Omacor 1 GM Oral CapsuleSYfb2141cd-6cff-470c-b776-4482afcebb412
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYfb2141cd-6cff-470c-b776-4482afcebb412
607044Lovaza 1 GM Oral CapsulePSN7892fb39-94c6-41cc-b8cd-d9d145180a961
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN7892fb39-94c6-41cc-b8cd-d9d145180a961
607044omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [Lovaza]SBD7892fb39-94c6-41cc-b8cd-d9d145180a961
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD7892fb39-94c6-41cc-b8cd-d9d145180a961
607044Lovaza 1000 MG (at least 900 MG) Oral CapsuleSY7892fb39-94c6-41cc-b8cd-d9d145180a961
607044Omacor 1 GM Oral CapsuleSY7892fb39-94c6-41cc-b8cd-d9d145180a961
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY7892fb39-94c6-41cc-b8cd-d9d145180a961