Loratadine

Product NDC
71309-007
11-digit product format
713090007
Labeler code
71309
Product ID
71309-007_b0c648f9-6ba1-9115-e053-2a95a90a0c0d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Safrel Pharmaceuticals, LLC
Application
ANDA210722
Marketing category
ANDA
Marketing start
2020-01-01
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71309-007-032024-01-30C16284748780-11030e365-2812-111a-e063-dadaa90a10e2Loratadine Tablets, 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-007-03Loratadine300 in 1 BOTTLETABLET3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-007LORATADINE TABLET [SAFREL PHARMACEUTICALS, LLC]1Legacy NDC, 1 package rows20201004_b0c64c16-3c05-e8e6-e053-2a95a90a533c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNb0c64c16-3c05-e8e6-e053-2a95a90a533c1
311372loratadine 10 MG Oral TabletSCDb0c64c16-3c05-e8e6-e053-2a95a90a533c1
311372loratadine 10 MG 24 HR Oral TabletSYb0c64c16-3c05-e8e6-e053-2a95a90a533c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71309-007-0371309000703300 TABLET in 1 BOTTLE (71309-007-03) 300 tablet2020-01-010000-00-00NoNoCurrent