Loratadine

Product NDC
68210-4126
11-digit product format
682104126
Labeler code
68210
Product ID
68210-4126_eea1dd7f-6cf4-880e-e053-2995a90adfdd
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
ANDA214684
Marketing category
ANDA
Marketing start
2021-04-07
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-4126-12024-01-30C16284748780-11030e365-1991-111a-e063-dadaa90a10e2Loratadine Tablets, 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4126-1Loratadine365 in 1 PACKAGETABLET3653

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4126LORATADINE TABLET [SPIRIT PHARMACEUTICALS LLC]3Legacy NDC, 1 package rows20221130_22adc4f4-e881-4253-8080-7ef49151055a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN22adc4f4-e881-4253-8080-7ef49151055a3
311372loratadine 10 MG Oral TabletSCD22adc4f4-e881-4253-8080-7ef49151055a3
311372loratadine 10 MG 24 HR Oral TabletSY22adc4f4-e881-4253-8080-7ef49151055a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4126-168210412601365 TABLET in 1 PACKAGE (68210-4126-1) 365 tablet2021-04-070000-00-00NoNoCurrent