FDA.reportPublic FDA data

Loratadine

Product NDC
0363-9787
11-digit product format
003639787
Labeler code
0363
Product ID
0363-9787_4653fa2a-b125-064a-e063-6294a90a963f
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA210722
Marketing category
ANDA
Marketing start
2024-01-01
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
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
0363-9787-01Loratadine10 in 1 BLISTER PACKTABLET104
0363-9787-02Loratadine20 in 1 BLISTER PACKTABLET204
0363-9787-14Loratadine5 in 1 BLISTER PACKTABLET54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9787LORATADINE TABLET [WALGREENS]3Current NDC, 3 package rows20241222_fd796139-ea9f-f4db-e053-6394a90acdf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNfd796139-ea9f-f4db-e053-6394a90acdf34
311372loratadine 10 MG Oral TabletSCDfd796139-ea9f-f4db-e053-6394a90acdf34
311372loratadine 10 MG 24 HR Oral TabletSYfd796139-ea9f-f4db-e053-6394a90acdf34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9787-010036397870110 TABLET in 1 BLISTER PACK (0363-9787-01) 10 tablet2024-01-01NoNoCurrent
0363-9787-020036397870220 TABLET in 1 BLISTER PACK (0363-9787-02) 20 tablet2024-01-01NoNoCurrent
0363-9787-14003639787145 TABLET in 1 BLISTER PACK (0363-9787-14) 5 tablet2024-01-01NoNoCurrent