LORATADINE

Product NDC
43598-707
11-digit product format
435980707
Labeler code
43598
Product ID
43598-707_2316deef-d945-4443-f3d3-dfca67b5439f
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA213294
Marketing category
ANDA
Marketing start
2021-05-19
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-707-30LORATADINE3 in 1 CARTONTABLET, ORALLY DISINTEGRATING31
43598-707-30LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-707LORATADINE TABLET, ORALLY DISINTEGRATING [DR. REDDY'S LABORATORIES INC.]1Current NDC, 2 package rows20230628_d707733d-1ee9-92d3-f5b2-3567b9c217c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSNd707733d-1ee9-92d3-f5b2-3567b9c217c21
311373loratadine 10 MG Disintegrating Oral TabletSCDd707733d-1ee9-92d3-f5b2-3567b9c217c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-707-30435980707303 BLISTER PACK in 1 CARTON (43598-707-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2023-07-01NoNoCurrent