Loratadine

Product NDC
55315-528
11-digit product format
553150528
Labeler code
55315
Product ID
55315-528_30c112e9-7c17-45cc-829d-d0cceea230c4
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Fred's Inc.
Application
ANDA076134
Marketing category
ANDA
Marketing start
2003-08-19
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55315-528-312025-01-30C16284748780-12cef2736-b687-d83d-e063-dadaa90ab31fDrug Facts
55315-528-692025-01-30C16284748780-12cef2736-b687-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-528-31Loratadine30 in 1 BLISTER PACKTABLET302
55315-528-69Loratadine10 in 1 BLISTER PACKTABLET102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [FRED'S INC.]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [FRED'S INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [FRED'S INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [FRED'S INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [FRED'S INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [FRED'S INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-528LORATADINE TABLET [FRED'S INC.]2Legacy NDC, 2 package rows20191219_3c7870d7-0f76-49be-bca4-459443ba9467.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN3c7870d7-0f76-49be-bca4-459443ba94672
311372loratadine 10 MG Oral TabletSCD3c7870d7-0f76-49be-bca4-459443ba94672
311372loratadine 10 MG 24 HR Oral TabletSY3c7870d7-0f76-49be-bca4-459443ba94672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-528-315531505283130 TABLET in 1 BLISTER PACK (55315-528-31) 30 tablet2003-08-190000-00-00NoNoCurrent
55315-528-695531505286910 TABLET in 1 BLISTER PACK (55315-528-69) 10 tablet2003-08-190000-00-00NoNoCurrent