loratadine

Product NDC
11822-0558
11-digit product format
118220558
Labeler code
11822
Product ID
11822-0558_63e2370f-747b-489f-95e9-e000aee12ae1
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA076011
Marketing category
ANDA
Marketing start
2020-07-17
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
Rxcui311373

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0558-02021-11-09C16284748780-1c7ccaba7-200d-fd44-e053-dadaa90aa01bRite Aid Corporation Loratadine Drug Facts
11822-0558-02021-07-23C16284748780-1c7ccaba7-200d-fd44-e053-dadaa90aa01bRite Aid Corporation Loratadine Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0558-0loratadine1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING14
11822-0558-0loratadine30 in 1 CARTONTABLET, ORALLY DISINTEGRATING304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0558LORATADINE TABLET, ORALLY DISINTEGRATING [RITE AID CORPORATION]4Current NDC, Legacy NDC, 2 package rows20231221_7b804f66-9323-4119-a856-1e6f08280781.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN7b804f66-9323-4119-a856-1e6f082807814
311373loratadine 10 MG Disintegrating Oral TabletSCD7b804f66-9323-4119-a856-1e6f082807814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0558-01182205580030 BLISTER PACK in 1 CARTON (11822-0558-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK30 blister pack2020-07-170000-00-00NoNoCurrent