Loratadine Allergy Relief

Product NDC
50090-2387
11-digit product format
500902387
Labeler code
50090
Product ID
50090-2387_236a2808-6a6e-444d-a03c-b2a7ac90c255
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076134
Marketing category
ANDA
Marketing start
2017-11-01
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
Loratadine Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2387-02023-02-07C16284748780-1f386c649-e991-0266-e053-dadaa90a7c1aLoratadine Allergy Relief
50090-2387-02023-01-30C16284748780-1f386c649-e991-0266-e053-dadaa90a7c1aLoratadine Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2387-0Loratadine Allergy Relief30 in 1 BLISTER PACKTABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2387-0EA - Each50090-2387a6f29983-88e4-4cb5-a176-ca1002e960e112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2387LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 1 package rows20240203_a53e5635-8633-4c28-b04f-cdfb3d851e68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNa53e5635-8633-4c28-b04f-cdfb3d851e6813
311372loratadine 10 MG Oral TabletSCDa53e5635-8633-4c28-b04f-cdfb3d851e6813
311372loratadine 10 MG 24 HR Oral TabletSYa53e5635-8633-4c28-b04f-cdfb3d851e6813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2387-05009023870030 TABLET in 1 BLISTER PACK (50090-2387-0) 30 tablet2017-11-010000-00-00NoNoCurrent