FDA.reportPublic FDA data

Loratadine Allergy Relief

Product NDC
67046-452
11-digit product format
670460452
Labeler code
67046
Product ID
67046-452_7df01850-e80c-8a5a-e053-2a91aa0a7886
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA076134
Marketing category
ANDA
Marketing start
2017-09-19
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-452-072022-01-28C16284748780-1d6a99b39-4fc0-a426-e053-dadaa90af4c2Drug Facts 452
67046-452-142022-01-28C16284748780-1d6a99b39-4fc0-a426-e053-dadaa90af4c2Drug Facts 452
67046-452-152022-01-28C16284748780-1d6a99b39-4fc0-a426-e053-dadaa90af4c2Drug Facts 452
67046-452-212022-01-28C16284748780-1d6a99b39-4fc0-a426-e053-dadaa90af4c2Drug Facts 452
67046-452-282022-01-28C16284748780-1d6a99b39-4fc0-a426-e053-dadaa90af4c2Drug Facts 452
67046-452-302022-01-28C16284748780-1d6a99b39-4fc0-a426-e053-dadaa90af4c2Drug Facts 452
67046-452-602022-01-28C16284748780-1d6a99b39-4fc0-a426-e053-dadaa90af4c2Drug Facts 452

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-452-07Loratadine Allergy Relief7 in 1 BLISTER PACKTABLET72
67046-452-14Loratadine Allergy Relief14 in 1 BLISTER PACKTABLET142
67046-452-15Loratadine Allergy Relief15 in 1 BLISTER PACKTABLET152
67046-452-21Loratadine Allergy Relief21 in 1 BLISTER PACKTABLET212
67046-452-28Loratadine Allergy Relief28 in 1 BLISTER PACKTABLET282
67046-452-30Loratadine Allergy Relief30 in 1 BLISTER PACKTABLET302
67046-452-60Loratadine Allergy Relief60 in 1 BLISTER PACKTABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-452LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 7 package rows20181227_5990445c-d522-24cf-e053-2991aa0af4e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN5990445c-d522-24cf-e053-2991aa0af4e62
311372loratadine 10 MG Oral TabletSCD5990445c-d522-24cf-e053-2991aa0af4e62
311372loratadine 10 MG 24 HR Oral TabletSY5990445c-d522-24cf-e053-2991aa0af4e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-452-07670460452077 TABLET in 1 BLISTER PACK (67046-452-07) 7 tablet2017-09-190000-00-00NoNoCurrent
67046-452-146704604521414 TABLET in 1 BLISTER PACK (67046-452-14) 14 tablet2017-09-190000-00-00NoNoCurrent
67046-452-156704604521515 TABLET in 1 BLISTER PACK (67046-452-15) 15 tablet2017-09-190000-00-00NoNoCurrent
67046-452-216704604522121 TABLET in 1 BLISTER PACK (67046-452-21) 21 tablet2017-09-190000-00-00NoNoCurrent
67046-452-286704604522828 TABLET in 1 BLISTER PACK (67046-452-28) 28 tablet2017-09-190000-00-00NoNoCurrent
67046-452-306704604523030 TABLET in 1 BLISTER PACK (67046-452-30) 30 tablet2017-09-190000-00-00NoNoCurrent
67046-452-606704604526060 TABLET in 1 BLISTER PACK (67046-452-60) 60 tablet2017-09-190000-00-00NoNoCurrent