Omega-3-Acid Ethyl Esters

Product NDC
49884-019
11-digit product format
498840019
Labeler code
49884
Product ID
49884-019_f93407ae-18bb-4a96-be66-35c819d356cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA091018
Marketing category
ANDA
Marketing start
2014-06-30
Marketing end
2021-03-31
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
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-019-08EA - Each49884-0194d618e81-7ac1-4066-96f1-a6e430d31f3a12014-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNc20f373a-8938-4430-ac6f-e3cd1269fc8d3
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDc20f373a-8938-4430-ac6f-e3cd1269fc8d3
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYc20f373a-8938-4430-ac6f-e3cd1269fc8d3
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNc9f470e5-ef40-4316-a767-a6d8866834d21
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDc9f470e5-ef40-4316-a767-a6d8866834d21
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYc9f470e5-ef40-4316-a767-a6d8866834d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-019-024988400190260 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49884-019-02) 2014-06-302021-03-31NoNoCurrent
49884-019-0849884001908120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49884-019-08) 2014-06-302021-03-31NoNoCurrent