OMEGA-3-ACID ETHYL ESTERS

Product NDC
70756-423
11-digit product format
707560423
Labeler code
70756
Product ID
70756-423_6576afc5-ca24-477d-b7ff-51ed56063309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA215458
Marketing category
ANDA
Marketing start
2021-11-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OMEGA-3-ACID ETHYL ESTERS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEGA-3-ACID ETHYL ESTERS1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD87YGH4Z0Q
Rxcui577208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-423-22OMEGA-3-ACID ETHYL ESTERS120 in 1 BOTTLECAPSULE, LIQUID FILLED12011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-423-22EA - Each70756-42376d4452c-2fce-494a-9592-4fcc8e6cabcc12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-423OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS CAPSULES) CAPSULE, LIQUID FILLED [LIFESTAR PHARMA LLC]8Current NDC, Legacy NDC, 1 package rows20220612_769ad170-5d70-4a54-995a-fef95ef503eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN769ad170-5d70-4a54-995a-fef95ef503eb11
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD769ad170-5d70-4a54-995a-fef95ef503eb11
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY769ad170-5d70-4a54-995a-fef95ef503eb11
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSNe40d55f2-db9f-4a48-8639-9aa7491e4de54
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCDe40d55f2-db9f-4a48-8639-9aa7491e4de54
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSYe40d55f2-db9f-4a48-8639-9aa7491e4de54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70756-423-2270756042322120 CAPSULE, LIQUID FILLED in 1 BOTTLE (70756-423-22) 2021-11-160000-00-00NoNoCurrent