Loratadine

Product NDC
0363-9994
11-digit product format
003639994
Labeler code
0363
Product ID
0363-9994_7aeb3f5b-33c7-4cf8-b6ab-5f3d211ea27c
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WALGREENS CO.
Application
ANDA210088
Marketing category
ANDA
Marketing start
2020-08-01
Substance
LORATADINE
Active strength
5 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
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui665078

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9994-30Loratadine10 in 1 BLISTER PACKTABLET, CHEWABLE104
0363-9994-30Loratadine3 in 1 CARTONTABLET, CHEWABLE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9994LORATADINE TABLET, CHEWABLE [WALGREENS CO.]4Current NDC, Legacy NDC, 2 package rows20220811_71adc5b3-3a91-4a1f-acb3-78922a7d9d5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN71adc5b3-3a91-4a1f-acb3-78922a7d9d5a4
665078loratadine 5 MG Chewable TabletSCD71adc5b3-3a91-4a1f-acb3-78922a7d9d5a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9994-30003639994303 BLISTER PACK in 1 CARTON (0363-9994-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2020-08-010000-00-00NoNoCurrent