Loratadine

Product NDC
50090-7752
11-digit product format
500907752
Labeler code
50090
Product ID
50090-7752_090d7586-b989-424e-adf0-85d1446f8a90
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208314
Marketing category
ANDA
Marketing start
2024-02-23
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7AJO3BO7QNLORATADINE79794-75-5LORATADINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7752-05009077520010 TABLET in 1 BOTTLE (50090-7752-0) 10 tablet2025-11-04NoNoHistorical
50090-7752-45009077520430 TABLET in 1 BOTTLE (50090-7752-4) 30 tablet2025-11-06NoNoHistorical
50090-7752-55009077520590 TABLET in 1 BOTTLE (50090-7752-5) 90 tablet2025-11-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Loratadine Tablets USP 10 mgA-S Medication Solutions2025-11-10Human OTC Drug Label2