FDA.reportPublic FDA data

Loratadine

Product NDC
63187-601
11-digit product format
631870601
Labeler code
63187
Product ID
63187-601_d36424c7-b438-4c23-884d-d4bfdac81fcf
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076301
Marketing category
ANDA
Marketing start
2008-10-15
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
Brand name suffix
antihistamine
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
63187-601-10Loratadineantihistamine10 in 1 BOTTLETABLET107
63187-601-14Loratadineantihistamine14 in 1 BOTTLETABLET147
63187-601-30Loratadineantihistamine30 in 1 BOTTLETABLET307
63187-601-60Loratadineantihistamine60 in 1 BOTTLETABLET607
63187-601-90Loratadineantihistamine90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-601-10EA - Each63187-601ab074e40-536d-4e72-b704-92c2443da46612017-11-06
63187-601-14EA - Each63187-601534a2dff-67c0-43d6-88a7-77cb3b83410812017-10-13
63187-601-60EA - Each63187-6019dfba4b5-2920-4d9a-ac54-7024d46fecdd12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-601LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PROFICIENT RX LP]7Current NDC, Legacy NDC, 5 package rows20220426_e9b87f79-ebed-4677-8e50-00cb4282ee56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNe9b87f79-ebed-4677-8e50-00cb4282ee567
311372loratadine 10 MG Oral TabletSCDe9b87f79-ebed-4677-8e50-00cb4282ee567
311372loratadine 10 MG 24 HR Oral TabletSYe9b87f79-ebed-4677-8e50-00cb4282ee567

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-601-106318706011010 TABLET in 1 BOTTLE (63187-601-10) 10 tablet2017-08-010000-00-00NoNoCurrent
63187-601-146318706011414 TABLET in 1 BOTTLE (63187-601-14) 14 tablet2017-08-010000-00-00NoNoCurrent
63187-601-306318706013030 TABLET in 1 BOTTLE (63187-601-30) 30 tablet2017-08-010000-00-00NoNoCurrent
63187-601-606318706016060 TABLET in 1 BOTTLE (63187-601-60) 60 tablet2017-08-010000-00-00NoNoCurrent
63187-601-906318706019090 TABLET in 1 BOTTLE (63187-601-90) 90 tablet2017-08-010000-00-00NoNoCurrent