Omega-3 Well Pack

Product NDC
69176-011
11-digit product format
691760011
Labeler code
69176
Product ID
69176-011_1eb20ef6-7a57-5b3e-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3 Well Pack
Dosage form
KIT
Route
ORAL
Labeler
TMIG, Inc.
Application
ANDA090973
Marketing category
ANDA
Marketing start
2015-09-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69176-011-012020-01-31C16284748780-19d75b9d0-4d95-f424-e053-dadaa90a57ceOmega-3, D-3 Wellness Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3170-7Omega-3 Well Pack1 in 1 BOTTLECAPSULE, LIQUID FILLED11 g1
69176-011-01Omega-3 Well Pack1 in 1 BOXKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69176-011-01EA - Each69176-0111df64510-8b9d-45b6-ae2b-cb6dbaf75f0f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEGA-3-ACID ETHYL ESTERSACTIVE INGREDIENTD87YGH4Z0QOMEGA-3 WELL PACK KIT [TMIG, INC.]1
VITAMIN DACTIVE INGREDIENT9VU1KI44GPOMEGA-3 WELL PACK KIT [TMIG, INC.]1
OMEGA-3 FATTY ACIDSACTIVE MOIETY71M78END5SOMEGA-3 WELL PACK KIT [TMIG, INC.]1
VITAMIN DACTIVE MOIETY9VU1KI44GPOMEGA-3 WELL PACK KIT [TMIG, INC.]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1OMEGA-3 WELL PACK KIT [TMIG, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEGA-3 WELL PACK KIT [TMIG, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OOMEGA-3 WELL PACK KIT [TMIG, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LOMEGA-3 WELL PACK KIT [TMIG, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOMEGA-3 WELL PACK KIT [TMIG, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEGA-3 WELL PACK KIT [TMIG, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEGA-3 WELL PACK KIT [TMIG, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEGA-3 WELL PACK KIT [TMIG, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEGA-3 WELL PACK KIT [TMIG, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROMEGA-3 WELL PACK KIT [TMIG, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69176-011OMEGA-3 WELL PACK KIT [TMIG, INC.]1Legacy NDC, 2 package rows20150902_1eb20ef6-7a56-5b3e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577208omega-3 acid ethyl esters 1 GM Oral CapsulePSN1eb20ef6-7a56-5b3e-e054-00144ff88e881
577208omega-3 acid ethyl esters (USP) 1000 MG Oral CapsuleSCD1eb20ef6-7a56-5b3e-e054-00144ff88e881
577208omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral CapsuleSY1eb20ef6-7a56-5b3e-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
60505-3170-7605053170071 in 1 BOTTLEHistorical
69176-011-01691760011011 in 1 BOXHistorical