FDA.reportPublic FDA data

Loratadine

Product NDC
50090-0838
11-digit product format
500900838
Labeler code
50090
Product ID
50090-0838_9ffc1763-9de3-4300-8e9b-6314c59027dd
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076471
Marketing category
ANDA
Marketing start
2005-01-24
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
50090-0838-02023-01-30C16284748780-1f386c649-e65b-0266-e053-dadaa90a7c1aLoratadine Tablet 10 mg
50090-0838-12023-01-30C16284748780-1f386c649-e65b-0266-e053-dadaa90a7c1aLoratadine Tablet 10 mg
50090-0838-32023-01-30C16284748780-1f386c649-e65b-0266-e053-dadaa90a7c1aLoratadine Tablet 10 mg
50090-0838-42023-01-30C16284748780-1f386c649-e65b-0266-e053-dadaa90a7c1aLoratadine Tablet 10 mg
50090-0838-52023-01-30C16284748780-1f386c649-e65b-0266-e053-dadaa90a7c1aLoratadine Tablet 10 mg
50090-0838-62023-01-30C16284748780-1f386c649-e65b-0266-e053-dadaa90a7c1aLoratadine Tablet 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0838-0Loratadine10 in 1 BOTTLETABLET1012
50090-0838-1Loratadine20 in 1 BOTTLETABLET2012
50090-0838-3Loratadine15 in 1 BOTTLETABLET1512
50090-0838-4Loratadine30 in 1 BOTTLETABLET3012
50090-0838-5Loratadine90 in 1 BOTTLETABLET9012
50090-0838-6Loratadine7 in 1 BOTTLETABLET712

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0838-0EA - Each50090-083816941f83-c16e-4e55-8909-52ec9f4346c012018-10-11
50090-0838-1EA - Each50090-0838ef3975af-88af-4879-8cf9-d846182cefcf12018-10-11
50090-0838-3EA - Each50090-08385c04ea3f-6a0f-4f6d-b2d9-9d1248b6b24012018-10-11
50090-0838-4EA - Each50090-0838298b86a0-158e-43bd-a17a-e9ebfe40868612018-10-11
50090-0838-5EA - Each50090-083889d04a35-9b65-4590-b453-511795851e0312018-10-11
50090-0838-6EA - Each50090-0838a3ac52be-36db-48e6-bcc9-c0c730b9021412018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0838LORATADINE TABLET [A-S MEDICATION SOLUTIONS]12Legacy NDC, 6 package rows20200122_04a49370-7617-4097-9921-75cbd9fc4420.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN04a49370-7617-4097-9921-75cbd9fc442012
311372loratadine 10 MG Oral TabletSCD04a49370-7617-4097-9921-75cbd9fc442012
311372loratadine 10 MG 24 HR Oral TabletSY04a49370-7617-4097-9921-75cbd9fc442012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0838-05009008380010 TABLET in 1 BOTTLE (50090-0838-0) 10 tablet2014-11-280000-00-00NoNoCurrent
50090-0838-15009008380120 TABLET in 1 BOTTLE (50090-0838-1) 20 tablet2014-11-280000-00-00NoNoCurrent
50090-0838-35009008380315 TABLET in 1 BOTTLE (50090-0838-3) 15 tablet2014-11-280000-00-00NoNoCurrent
50090-0838-45009008380430 TABLET in 1 BOTTLE (50090-0838-4) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0838-55009008380590 TABLET in 1 BOTTLE (50090-0838-5) 90 tablet2014-11-280000-00-00NoNoCurrent
50090-0838-6500900838067 TABLET in 1 BOTTLE (50090-0838-6) 7 tablet2014-11-280000-00-00NoNoCurrent