FDA.reportPublic FDA data

Genexa Acetaminophen

Product NDC
69676-0059
11-digit product format
696760059
Labeler code
69676
Product ID
69676-0059_51590662-8dac-1b90-e063-6294a90a49a2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Genexa Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-17
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Genexa Acetaminophen
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0059-22025-02-26C16284748780-12cef2736-92bf-d83d-e063-dadaa90ab31fAcetaminophen Extra Strength Caplets
69676-0059-52025-02-26C16284748780-12cef2736-92bf-d83d-e063-dadaa90ab31fAcetaminophen Extra Strength Caplets
69676-0059-22025-01-30C16284748780-12cef2736-92bf-d83d-e063-dadaa90ab31fAcetaminophen Extra Strength Caplets
69676-0059-52025-01-30C16284748780-12cef2736-92bf-d83d-e063-dadaa90ab31fAcetaminophen Extra Strength Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0059-2Genexa AcetaminophenExtra Strength100 in 1 BOTTLETABLET, COATED1007
69676-0059-2Genexa AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
69676-0059-5Genexa AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
69676-0059-5Genexa AcetaminophenExtra Strength50 in 1 BOTTLETABLET, COATED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0059GENEXA ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [GENEXA INC.]5Current NDC, Legacy NDC, 4 package rows20250228_d6f968ca-719f-5a68-e053-2995a90a4afa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNd6f968ca-719f-5a68-e053-2995a90a4afa7
198440acetaminophen 500 MG Oral TabletSCDd6f968ca-719f-5a68-e053-2995a90a4afa7
198440APAP 500 MG Oral TabletSYd6f968ca-719f-5a68-e053-2995a90a4afa7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69676-0059-2696760059021 BOTTLE in 1 CARTON (69676-0059-2) / 100 TABLET, COATED in 1 BOTTLE1 bottle2022-02-170000-00-00NoNoCurrent
69676-0059-5696760059051 BOTTLE in 1 CARTON (69676-0059-5) / 50 TABLET, COATED in 1 BOTTLE1 bottle2022-02-170000-00-00NoNoCurrent