Loratadine Allergy Relief

Product NDC
53943-975
11-digit product format
539430975
Labeler code
53943
Product ID
53943-975_4ee4c604-4a18-4955-8b5e-b2eeff1cb7f8
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
ANDA076134
Marketing category
ANDA
Marketing start
2017-11-01
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 Allergy Relief
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
53943-975-30Loratadine Allergy Relief30 in 1 BLISTER PACKTABLET301
53943-975-60Loratadine Allergy Relief60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-975LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [DISCOUNT DRUG MART]1Current NDC, Legacy NDC, 2 package rows20180917_55d3ee36-116b-4ec6-b409-79d67a2b54ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN55d3ee36-116b-4ec6-b409-79d67a2b54ae1
311372loratadine 10 MG Oral TabletSCD55d3ee36-116b-4ec6-b409-79d67a2b54ae1
311372loratadine 10 MG 24 HR Oral TabletSY55d3ee36-116b-4ec6-b409-79d67a2b54ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-975-305394309753030 TABLET in 1 BLISTER PACK (53943-975-30) 30 tablet2017-11-010000-00-00NoNoCurrent
53943-975-605394309756060 TABLET in 1 BOTTLE (53943-975-60) 60 tablet2017-11-010000-00-00NoNoCurrent