Loratadine

Product NDC
68016-526
11-digit product format
680160526
Labeler code
68016
Product ID
68016-526_78c14cff-325e-4106-a9a4-cb5281ceec58
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Premier Value
Application
ANDA076134
Marketing category
ANDA
Marketing start
2003-08-19
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
Loratadine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-526-31Loratadine30 in 1 BLISTER PACKTABLET302
68016-526-60Loratadine60 in 1 BOTTLETABLET602
68016-526-69Loratadine10 in 1 BLISTER PACKTABLET102
68016-526-90Loratadine90 in 1 BOTTLETABLET902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [PREMIER VALUE]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [PREMIER VALUE]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [PREMIER VALUE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [PREMIER VALUE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [PREMIER VALUE]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [PREMIER VALUE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-526LORATADINE TABLET [PREMIER VALUE]2Current NDC, Legacy NDC, 4 package rows20180115_778a6979-ea47-4381-8c40-84b3c2325a7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN778a6979-ea47-4381-8c40-84b3c2325a7e2
311372loratadine 10 MG Oral TabletSCD778a6979-ea47-4381-8c40-84b3c2325a7e2
311372loratadine 10 MG 24 HR Oral TabletSY778a6979-ea47-4381-8c40-84b3c2325a7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-526-316801605263130 TABLET in 1 BLISTER PACK (68016-526-31) 30 tablet2003-08-190000-00-00NoNoCurrent
68016-526-606801605266060 TABLET in 1 BOTTLE (68016-526-60) 60 tablet2003-08-190000-00-00NoNoCurrent
68016-526-696801605266910 TABLET in 1 BLISTER PACK (68016-526-69) 10 tablet2003-08-190000-00-00NoNoCurrent
68016-526-906801605269090 TABLET in 1 BOTTLE (68016-526-90) 90 tablet2003-08-190000-00-00NoNoCurrent