FDA.reportPublic FDA data

LORATADINE

Product NDC
72888-029
11-digit product format
728880029
Labeler code
72888
Product ID
72888-029_47a189dc-792d-a279-e063-6394a90a9adf
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA214280
Marketing category
ANDA
Marketing start
2020-09-10
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311373

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-029-09LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING102
72888-029-09LORATADINE1 in 1 CARTONTABLET, ORALLY DISINTEGRATING12
72888-029-11LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING102
72888-029-11LORATADINE3 in 1 CARTONTABLET, ORALLY DISINTEGRATING32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-029-09EA - Each72888-02902ce73c3-076c-4525-8a91-fd14e71dac4712022-09-12
72888-029-11EA - Each72888-0295299bbaa-521d-4535-8074-209b5dceb05412022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-029LORATADINE TABLET, ORALLY DISINTEGRATING [ADVAGEN PHARMA LIMITED]1Current NDC, Legacy NDC, 4 package rows20200926_a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSNa5699a95-c0a7-43ea-9bab-bbfaba3c8aa52
311373loratadine 10 MG Disintegrating Oral TabletSCDa5699a95-c0a7-43ea-9bab-bbfaba3c8aa52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-029-09728880029091 BLISTER PACK in 1 CARTON (72888-029-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2020-09-100000-00-00NoNoCurrent
72888-029-11728880029113 BLISTER PACK in 1 CARTON (72888-029-11) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2020-09-100000-00-00NoNoCurrent