Loratadine

Product NDC
60505-0147
11-digit product format
605050147
Labeler code
60505
Product ID
60505-0147_c15c5b51-bc6a-e99e-e5e7-52e61c5da7b0
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA076471
Marketing category
ANDA
Marketing start
2005-01-24
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0147-1Loratadine100 in 1 BOTTLETABLET1009
60505-0147-8Loratadine1000 in 1 BOTTLETABLET10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0147LORATADINE TABLET [APOTEX CORP.]8Current NDC, Legacy NDC, 2 package rows20240927_679164cc-7505-7ed4-13fe-87f06cb777d8.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
311372loratadine 10 MG 24HR Oral TabletPSN679164cc-7505-7ed4-13fe-87f06cb777d89
311372loratadine 10 MG Oral TabletSCD679164cc-7505-7ed4-13fe-87f06cb777d89
311372loratadine 10 MG 24 HR Oral TabletSY679164cc-7505-7ed4-13fe-87f06cb777d89
311372loratadine 10 MG 24HR Oral TabletPSN0fc465dc-f0d8-06dc-e054-00144ff8d46c1
311372loratadine 10 MG Oral TabletSCD0fc465dc-f0d8-06dc-e054-00144ff8d46c1
311372loratadine 10 MG 24 HR Oral TabletSY0fc465dc-f0d8-06dc-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0147-160505014701100 TABLET in 1 BOTTLE (60505-0147-1) 100 tablet2005-01-242022-06-30NoNoCurrent
60505-0147-8605050147081000 TABLET in 1 BOTTLE (60505-0147-8) 1000 tablet2005-01-240000-00-00NoNoCurrent