LOVAZA

Product NDC
17856-0084
11-digit product format
178560084
Labeler code
17856
Product ID
17856-0084_99a1ceca-cb48-4386-8a0c-6e53c62b4a30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Atlantic Biologicals Corps
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
E
Listing certified through
2018-12-31
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
17856-0084-1LOVAZA50 in 1 CUP, UNIT-DOSECAPSULE, LIQUID FILLED502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0084LOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 1 package rows20161202_56fa49bf-ee99-4152-aa21-072128738afb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607044Lovaza 1 GM Oral CapsulePSN56fa49bf-ee99-4152-aa21-072128738afb2
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN56fa49bf-ee99-4152-aa21-072128738afb2
607044omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [Lovaza]SBD56fa49bf-ee99-4152-aa21-072128738afb2
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD56fa49bf-ee99-4152-aa21-072128738afb2
607044Lovaza 1000 MG (at least 900 MG) Oral CapsuleSY56fa49bf-ee99-4152-aa21-072128738afb2
607044Omacor 1 GM Oral CapsuleSY56fa49bf-ee99-4152-aa21-072128738afb2
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY56fa49bf-ee99-4152-aa21-072128738afb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17856-0084-11785600840150 in 1 CUP, UNIT-DOSEHistorical