LOVAZA

Product NDC
69784-420
11-digit product format
697840420
Labeler code
69784
Product ID
69784-420_9701e2b4-980f-434b-a298-349ba5675d65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-Acid Ethyl Esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Woodward Pharma Services LLC
Application
ANDA204940
Marketing category
ANDA
Marketing start
2015-11-30
Marketing end
0000-00-00
Substance
OMEGA-3-ACID ETHYL ESTERS
Active strength
1 g/1
Pharmacologic classes
Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-420-12EA - Each69784-420cc2eb24e-3f55-4cc3-afb2-a55ce00b9deb12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-420LOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [WOODWARD PHARMA SERVICES LLC]8Legacy NDC20241213_c1920576-1b04-4b20-bb00-061f09032574.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69784-420-1269784042012120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69784-420-12) 2015-11-300000-00-00NoNoCurrent
69784-420-3669784042036360 CAPSULE, LIQUID FILLED in 1 BOTTLE (69784-420-36) 2015-11-300000-00-00NoNoCurrent
69784-420-606978404206060 CAPSULE, LIQUID FILLED in 1 BOTTLE (69784-420-60) 2015-11-300000-00-00NoNoCurrent