LORATADINE

Product NDC
73629-003
11-digit product format
736290003
Labeler code
73629
Product ID
73629-003_2b3b13e2-8085-77d5-e063-6394a90a0a58
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET
Route
ORAL
Labeler
AMZ789 LLC
Application
ANDA210722
Marketing category
ANDA
Marketing start
2022-03-30
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
73629-003-18LORATADINE180 in 1 BOTTLETABLET1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73629-003LORATADINE TABLET [AMZ789 LLC]2Current NDC, Legacy NDC, 1 package rows20250110_db71197e-d633-644d-e053-2a95a90a261d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNdb71197e-d633-644d-e053-2a95a90a261d2
311372loratadine 10 MG Oral TabletSCDdb71197e-d633-644d-e053-2a95a90a261d2
311372loratadine 10 MG 24 HR Oral TabletSYdb71197e-d633-644d-e053-2a95a90a261d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73629-003-1873629000318180 TABLET in 1 BOTTLE (73629-003-18) 180 tablet2022-03-300000-00-00NoNoCurrent