FDA.reportPublic FDA data

Allergy Relief

Product NDC
69168-309
11-digit product format
691680309
Labeler code
69168
Product ID
69168-309_520a7a7c-a1a5-48a6-b472-9d47a4463452
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA076471
Marketing category
ANDA
Marketing start
2014-12-16
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-309-082020-03-13C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-092020-03-13C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-102020-03-13C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-302020-03-13C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-082020-01-31C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-092020-01-31C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-102020-01-31C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief
69168-309-302020-01-31C16284748780-19d75b9d0-1d1d-f424-e053-dadaa90a57ce309 - Health A2Z Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-309-03Allergy Relief30 in 1 BLISTER PACKTABLET306
69168-309-08Allergy Relief5 in 1 BLISTER PACKTABLET56
69168-309-08Allergy Relief1 in 1 CARTONTABLET16
69168-309-09Allergy Relief10 in 1 BLISTER PACKTABLET106
69168-309-09Allergy Relief1 in 1 CARTONTABLET16
69168-309-10Allergy Relief1000 in 1 BOTTLETABLET10006
69168-309-30Allergy Relief1 in 1 CARTONTABLET16
69168-309-30Allergy Relief30 in 1 BOTTLETABLET306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
LORATADINEACTIVE MOIETY7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-309ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 8 package rows20241206_0991388a-2eb8-4913-9efc-adf411eddf3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN0991388a-2eb8-4913-9efc-adf411eddf3a6
311372loratadine 10 MG Oral TabletSCD0991388a-2eb8-4913-9efc-adf411eddf3a6
311372loratadine 10 MG 24 HR Oral TabletSY0991388a-2eb8-4913-9efc-adf411eddf3a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-309-036916803090330 TABLET in 1 BLISTER PACK (69168-309-03) 30 tablet2014-12-16NoNoCurrent
69168-309-08691680309081 BLISTER PACK in 1 CARTON (69168-309-08) / 5 TABLET in 1 BLISTER PACK1 blister pack2014-12-160000-00-00NoNoCurrent
69168-309-09691680309091 BLISTER PACK in 1 CARTON (69168-309-09) / 10 TABLET in 1 BLISTER PACK1 blister pack2014-12-160000-00-00NoNoCurrent
69168-309-10691680309101000 TABLET in 1 BOTTLE (69168-309-10) 1000 tablet2014-12-160000-00-00NoNoCurrent
69168-309-30691680309301 BOTTLE in 1 CARTON (69168-309-30) > 30 TABLET in 1 BOTTLE1 bottle2014-12-160000-00-00NoNoCurrent