LOVAZA

Product NDC
17856-0783
11-digit product format
178560783
Labeler code
17856
Product ID
17856-0783_7cc7dd8e-0094-446c-8d32-d3c706b92c78
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
2008-10-21
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
17856-0783-2LOVAZA1 in 1 CUPCAPSULE, LIQUID FILLED13
17856-0783-9LOVAZA1 in 1 POUCHCAPSULE, LIQUID FILLED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0783LOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [ATLANTIC BIOLOGICALS CORPS]3Legacy NDC, 2 package rows20160504_e8adf027-a288-43bf-961d-088fe1028047.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17856-0783-2178560783021 in 1 CUPHistorical
17856-0783-9178560783091 in 1 POUCHHistorical