LORATADINE

Product NDC
49738-686
11-digit product format
497380686
Labeler code
49738
Product ID
49738-686_6c556dbe-66fd-907c-e053-2991aa0a475d
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
SMART SENSE (KMART)
Application
ANDA206214
Marketing category
ANDA
Marketing start
2017-01-31
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
Rxcui828269

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49738-686-07LORATADINE10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
49738-686-30LORATADINE30 in 1 BLISTER PACKCAPSULE, LIQUID FILLED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49738-686LORATADINE CAPSULE, LIQUID FILLED [SMART SENSE (KMART)]2Current NDC, Legacy NDC, 2 package rows20180529_c2db3398-ead6-4bb6-8aa6-f1366a846144.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSNc2db3398-ead6-4bb6-8aa6-f1366a8461442
828269loratadine 10 MG Oral CapsuleSCDc2db3398-ead6-4bb6-8aa6-f1366a8461442
828269loratadine 10 MG 24HR Oral CapsuleSYc2db3398-ead6-4bb6-8aa6-f1366a8461442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49738-686-074973806860710 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49738-686-07) 2017-01-310000-00-00NoNoCurrent
49738-686-304973806863030 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49738-686-30) 2017-01-310000-00-00NoNoCurrent