FDA.reportPublic FDA data

Loratadine Allergy Relief

Product NDC
71335-0100
11-digit product format
713350100
Labeler code
71335
Product ID
71335-0100_ca06cd0b-6979-4948-91c4-8635aec581c9
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076134
Marketing category
ANDA
Marketing start
2017-11-01
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 Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0100-12024-05-17C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-22024-05-17C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-32024-05-17C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-42024-05-17C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-52024-05-17C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-62024-05-17C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-72024-05-17C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-82024-05-17C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-92024-05-17C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-12024-01-30C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-22024-01-30C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-32024-01-30C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-42024-01-30C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-52024-01-30C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-62024-01-30C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-72024-01-30C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-82024-01-30C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief
71335-0100-92024-01-30C16284748780-11030e365-27d1-111a-e063-dadaa90a10e2Loratadine Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0100-1Loratadine Allergy Relief20 in 1 BOTTLETABLET205
71335-0100-2Loratadine Allergy Relief30 in 1 BOTTLETABLET305
71335-0100-3Loratadine Allergy Relief60 in 1 BOTTLETABLET605
71335-0100-4Loratadine Allergy Relief14 in 1 BOTTLETABLET145
71335-0100-5Loratadine Allergy Relief10 in 1 BOTTLETABLET105
71335-0100-6Loratadine Allergy Relief90 in 1 BOTTLETABLET905
71335-0100-7Loratadine Allergy Relief28 in 1 BOTTLETABLET285
71335-0100-8Loratadine Allergy Relief15 in 1 BOTTLETABLET155
71335-0100-9Loratadine Allergy Relief100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0100-1EA - Each71335-010034343ea0-ada4-451a-9035-b1924f1a12fb12018-03-08
71335-0100-2EA - Each71335-01002889a0ef-62f5-4dd5-8c5f-983ca3a9d6b912018-03-08
71335-0100-3EA - Each71335-0100af1bfd66-0af9-4a34-8cb4-da157e5542bc12018-03-08
71335-0100-4EA - Each71335-0100ae156eec-51bb-4dad-90c8-b81d3c85e4fd12018-03-08
71335-0100-5EA - Each71335-0100d7aadc63-53e8-4a69-8fe3-783c54e196d712018-03-08
71335-0100-6EA - Each71335-010031fd7d84-6bb4-4d6b-9ef7-ce73991095d712018-03-08
71335-0100-7EA - Each71335-0100ec50d2e9-61e1-4655-b4d7-54a160362e8312018-03-08
71335-0100-8EA - Each71335-01003454f43c-0a35-4aef-b31d-6e5f3f37de9712018-03-08
71335-0100-9EA - Each71335-0100bce5163b-9526-46e7-9a96-5c7afd04bece12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0100LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 9 package rows20240518_40914eeb-3a85-4691-9fb8-2df72ba1f709.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN40914eeb-3a85-4691-9fb8-2df72ba1f7095
311372loratadine 10 MG Oral TabletSCD40914eeb-3a85-4691-9fb8-2df72ba1f7095
311372loratadine 10 MG 24 HR Oral TabletSY40914eeb-3a85-4691-9fb8-2df72ba1f7095

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0100-17133501000120 TABLET in 1 BOTTLE (71335-0100-1) 20 tablet2018-02-120000-00-00NoNoCurrent
71335-0100-27133501000230 TABLET in 1 BOTTLE (71335-0100-2) 30 tablet2018-02-230000-00-00NoNoCurrent
71335-0100-37133501000360 TABLET in 1 BOTTLE (71335-0100-3) 60 tablet2021-12-270000-00-00NoNoCurrent
71335-0100-47133501000414 TABLET in 1 BOTTLE (71335-0100-4) 14 tablet2021-12-270000-00-00NoNoCurrent
71335-0100-57133501000510 TABLET in 1 BOTTLE (71335-0100-5) 10 tablet2018-02-200000-00-00NoNoCurrent
71335-0100-67133501000690 TABLET in 1 BOTTLE (71335-0100-6) 90 tablet2018-02-090000-00-00NoNoCurrent
71335-0100-77133501000728 TABLET in 1 BOTTLE (71335-0100-7) 28 tablet2024-04-050000-00-00NoNoCurrent
71335-0100-87133501000815 TABLET in 1 BOTTLE (71335-0100-8) 15 tablet2024-04-050000-00-00NoNoCurrent
71335-0100-971335010009100 TABLET in 1 BOTTLE (71335-0100-9) 100 tablet2024-04-050000-00-00NoNoCurrent