FDA.reportPublic FDA data

LOVAZA

Product NDC
21695-795
11-digit product format
216950795
Labeler code
21695
Product ID
21695-795_7892fb39-94c6-41cc-b8cd-d9d145180a96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021654
Marketing category
NDA
Marketing start
2008-10-21
Marketing end
0000-00-00
Substance
OMEGA-3-ACID ETHYL ESTERS
Active strength
1 g/1
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-795-722019-09-24C16284748780-1934fe258-4ad6-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use LOVAZA safely and effectively. See full prescribing information for LOVAZA. LOVAZA ® (omega-3-acid ethyl esters) Capsules Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-795-72LOVAZA120 in 1 BOTTLECAPSULE, LIQUID FILLED1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-795-72EA - Each21695-79527f40303-3fe0-4d8a-8561-65729362ad8412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEGA-3-ACID ETHYL ESTERSACTIVE INGREDIENTD87YGH4Z0QLOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-795LOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_7892fb39-94c6-41cc-b8cd-d9d145180a96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-795-7221695079572120 in 1 BOTTLEHistorical