Loratadine

Product NDC
0363-9603
11-digit product format
003639603
Labeler code
0363
Product ID
0363-9603_0e58f8c9-b80a-4711-b5a0-e61954520d96
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA208314
Marketing category
ANDA
Marketing start
2021-07-03
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
0363-9603-09Loratadine30 in 1 BOTTLETABLET304
0363-9603-09Loratadine1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9603LORATADINE TABLET [WALGREEN CO.]4Current NDC, Legacy NDC, 2 package rows20240626_c016aad8-df83-99b0-e053-2a95a90a49cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNc016aad8-df83-99b0-e053-2a95a90a49cf4
311372loratadine 10 MG Oral TabletSCDc016aad8-df83-99b0-e053-2a95a90a49cf4
311372loratadine 10 MG 24 HR Oral TabletSYc016aad8-df83-99b0-e053-2a95a90a49cf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9603-09003639603091 BOTTLE in 1 CARTON (0363-9603-09) / 30 TABLET in 1 BOTTLE1 bottle2021-07-030000-00-00NoNoCurrent