ALLERGY RELIEF

Product NDC
55681-303
11-digit product format
556810303
Labeler code
55681
Product ID
55681-303_4e68e4e1-8a60-a8f1-e063-6394a90ac63b
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET
Route
ORAL
Labeler
TWIN MED LLC
Application
ANDA210722
Marketing category
ANDA
Marketing start
2022-03-02
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ALLERGY RELIEF
Brand name suffix
10 mg
Listing expiration
2027-12-31

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
55681-303-03ALLERGY RELIEF10 mg300 in 1 BOTTLETABLET3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-303ALLERGY RELIEF 10 MG (LORATADINE) TABLET [TWIN MED LLC]3Current NDC, Legacy NDC, 1 package rows20240104_d943f548-aa0d-4476-e053-2a95a90a7bd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNd943f548-aa0d-4476-e053-2a95a90a7bd44
311372loratadine 10 MG Oral TabletSCDd943f548-aa0d-4476-e053-2a95a90a7bd44
311372loratadine 10 MG 24 HR Oral TabletSYd943f548-aa0d-4476-e053-2a95a90a7bd44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55681-303-0355681030303300 TABLET in 1 BOTTLE (55681-303-03) 300 tablet2022-03-020000-00-00NoNoCurrent