Loratadine

Product NDC
46122-158
11-digit product format
461220158
Labeler code
46122
Product ID
46122-158_edba298d-ed0a-4f7e-a1b0-0afff57a1edd
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Amerisource Bergen
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-158-652020-01-31C16284748780-19d75b9d0-eb06-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-158-65Loratadine30 in 1 BLISTER PACKTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-158-65EA - Each46122-1582f7e0e1e-5629-4c42-a378-12a9e6523b5412013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-158LORATADINE TABLET [AMERISOURCE BERGEN]1Legacy NDC, 1 package rows20130305_309c3651-d18d-43d5-b715-ca7602397d2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN309c3651-d18d-43d5-b715-ca7602397d2f1
311372loratadine 10 MG Oral TabletSCD309c3651-d18d-43d5-b715-ca7602397d2f1
311372loratadine 10 MG 24 HR Oral TabletSY309c3651-d18d-43d5-b715-ca7602397d2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46122-158-654612201586530 in 1 BLISTER PACKHistorical