FDA.reportPublic FDA data

Loratadine Allergy Relief

Product NDC
63187-100
11-digit product format
631870100
Labeler code
63187
Product ID
63187-100_91a17d89-5112-4176-bfa0-9fd2d27922c5
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076134
Marketing category
ANDA
Marketing start
2003-08-28
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
63187-100-10Loratadine Allergy Relief10 in 1 BOTTLETABLET106
63187-100-20Loratadine Allergy Relief20 in 1 BOTTLETABLET206
63187-100-30Loratadine Allergy Relief30 in 1 BOTTLETABLET306
63187-100-90Loratadine Allergy Relief90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-100LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20241013_a6b9a1bf-1013-4a15-b3b2-a226a75a1ffb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNa6b9a1bf-1013-4a15-b3b2-a226a75a1ffb6
311372loratadine 10 MG Oral TabletSCDa6b9a1bf-1013-4a15-b3b2-a226a75a1ffb6
311372loratadine 10 MG 24 HR Oral TabletSYa6b9a1bf-1013-4a15-b3b2-a226a75a1ffb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-100-106318701001010 TABLET in 1 BOTTLE (63187-100-10) 10 tablet2019-01-010000-00-00NoNoCurrent
63187-100-206318701002020 TABLET in 1 BOTTLE (63187-100-20) 20 tablet2019-01-010000-00-00NoNoCurrent
63187-100-306318701003030 TABLET in 1 BOTTLE (63187-100-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-100-906318701009090 TABLET in 1 BOTTLE (63187-100-90) 90 tablet2024-10-10NoNoHistorical