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#

DailyMed Package Descriptions#

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

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