Loratadine

Product NDC
50090-7158
11-digit product format
500907158
Labeler code
50090
Product ID
50090-7158_1bc6f73c-94c6-47fb-8afa-2f7f8e8b88b5
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
50090-7158-05009071580030 TABLET in 1 BOTTLE (50090-7158-0) 30 tablet2024-05-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Major Pharmaceuticals Allergy Drug FactsA-S Medication Solutions2025-11-06HUMAN OTC DRUG LABEL6
Major Pharmaceuticals Allergy Drug FactsA-S Medication Solutions2024-05-29HUMAN OTC DRUG LABEL4