Loratadine

Product NDC
50090-5532
11-digit product format
500905532
Labeler code
50090
Product ID
50090-5532_4e8b7bd8-7ff5-4683-942e-a05187095c81
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076301
Marketing category
ANDA
Marketing start
2005-02-21
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
50090-5532-05009055320010 TABLET in 1 BOTTLE (50090-5532-0) 10 tablet2021-10-28NoNoHistorical
50090-5532-45009055320430 TABLET in 1 BOTTLE (50090-5532-4) 30 tablet2021-10-28NoNoHistorical
50090-5532-55009055320590 TABLET in 1 BOTTLE (50090-5532-5) 90 tablet2021-04-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Major Pharmaceuticals Allergy Drug FactsA-S Medication Solutions2025-11-06HUMAN OTC DRUG LABEL8
Major Pharmaceuticals Allergy Drug FactsA-S Medication Solutions2024-01-23HUMAN OTC DRUG LABEL5