Loratadine

Product NDC
68788-7291
11-digit product format
687887291
Labeler code
68788
Product ID
68788-7291_6968b46b-fa63-4f8e-b01f-3be9dd45e177
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077421
Marketing category
ANDA
Marketing start
2019-01-22
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7291-1ML - Milliliter68788-7291877eafea-3e74-4cee-a663-b73fdd13082f12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7291LORATADINE SOLUTION [PREFERRED PHARMACEUTICALS INC.]6Legacy NDC20240627_80b899df-a426-46c6-92e6-348a868b1712.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7291-168788729101120 mL in 1 CARTON (68788-7291-1) 120 ml2019-01-220000-00-00NoNoCurrent