Loratadine

Product NDC
68071-3414
11-digit product format
680713414
Labeler code
68071
Product ID
68071-3414_2d6c6076-d7cb-e793-e063-6294a90ac3b0
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076301
Marketing category
ANDA
Marketing start
2008-10-15
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
68071-3414-3680713414031 BOTTLE in 1 CARTON (68071-3414-3) / 30 TABLET in 1 BOTTLE1 bottle2023-05-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Perrigo Loratadine Tablets, 10 mg Drug FactsNuCare Pharmaceuticals,Inc.2025-02-05HUMAN OTC DRUG LABEL3