FDA.reportPublic FDA data

Loratadine

Product NDC
58602-702
11-digit product format
586020702
Labeler code
58602
Product ID
58602-702_94169799-0508-439b-93c5-132b9e6ae767
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA208314
Marketing category
ANDA
Marketing start
2018-04-16
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
58602-702-04Loratadine10 in 1 CARTONTABLET1010
58602-702-04Loratadine10 in 1 BLISTER PACKTABLET1010
58602-702-05Loratadine5 in 1 CARTONTABLET510
58602-702-05Loratadine10 in 1 BLISTER PACKTABLET1010
58602-702-09Loratadine30 in 1 BOTTLETABLET3010
58602-702-09Loratadine1 in 1 CARTONTABLET110
58602-702-15Loratadine1 in 1 CARTONTABLET110
58602-702-15Loratadine60 in 1 BOTTLETABLET6010
58602-702-17Loratadine45 in 1 BOTTLETABLET4510
58602-702-17Loratadine1 in 1 CARTONTABLET110
58602-702-19Loratadine1 in 1 CARTONTABLET110
58602-702-19Loratadine90 in 1 BOTTLETABLET9010
58602-702-21Loratadine100 in 1 BOTTLETABLET10010
58602-702-21Loratadine1 in 1 CARTONTABLET110
58602-702-23Loratadine120 in 1 BOTTLETABLET12010
58602-702-23Loratadine1 in 1 CARTONTABLET110
58602-702-29Loratadine1 in 1 CARTONTABLET110
58602-702-29Loratadine150 in 1 BOTTLETABLET15010
58602-702-32Loratadine1 in 1 CARTONTABLET110
58602-702-32Loratadine180 in 1 BOTTLETABLET18010
58602-702-38Loratadine1 in 1 CARTONTABLET110
58602-702-38Loratadine300 in 1 BOTTLETABLET30010
58602-702-39Loratadine365 in 1 BOTTLETABLET36510
58602-702-39Loratadine1 in 1 CARTONTABLET110
58602-702-40Loratadine500 in 1 BOTTLETABLET50010
58602-702-40Loratadine1 in 1 CARTONTABLET110
58602-702-44Loratadine400 in 1 BOTTLETABLET40010
58602-702-44Loratadine1 in 1 CARTONTABLET110
58602-702-54Loratadine1 in 1 CARTONTABLET110
58602-702-54Loratadine70 in 1 BOTTLETABLET7010
58602-702-60Loratadine5 in 1 BLISTER PACKTABLET510
58602-702-60Loratadine1 in 1 CARTONTABLET110
58602-702-67Loratadine10 in 1 BLISTER PACKTABLET1010
58602-702-67Loratadine2 in 1 CARTONTABLET210
58602-702-81Loratadine108 in 1 BOTTLETABLET10810
58602-702-81Loratadine1 in 1 CARTONTABLET110
58602-702-83Loratadine10 in 1 BLISTER PACKTABLET1010
58602-702-83Loratadine1 in 1 CARTONTABLET110
58602-702-84Loratadine3 in 1 CARTONTABLET310
58602-702-84Loratadine10 in 1 BLISTER PACKTABLET1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-702LORATADINE TABLET [AUROHEALTH LLC]10Current NDC, Legacy NDC, 40 package rows20200814_196da80c-3dbb-40c7-ac93-8a57d6acb1c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN196da80c-3dbb-40c7-ac93-8a57d6acb1c310
311372loratadine 10 MG Oral TabletSCD196da80c-3dbb-40c7-ac93-8a57d6acb1c310
311372loratadine 10 MG 24 HR Oral TabletSY196da80c-3dbb-40c7-ac93-8a57d6acb1c310
311372loratadine 10 MG 24HR Oral TabletPSN7ca5050a-328a-4aff-8954-58f092e3ed6b1
311372loratadine 10 MG Oral TabletSCD7ca5050a-328a-4aff-8954-58f092e3ed6b1
311372loratadine 10 MG 24 HR Oral TabletSY7ca5050a-328a-4aff-8954-58f092e3ed6b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-702-045860207020410 BLISTER PACK in 1 CARTON (58602-702-04) / 10 TABLET in 1 BLISTER PACK10 blister pack2020-02-100000-00-00NoNoCurrent
58602-702-05586020702055 BLISTER PACK in 1 CARTON (58602-702-05) / 10 TABLET in 1 BLISTER PACK5 blister pack2018-04-160000-00-00NoNoCurrent
58602-702-09586020702091 BOTTLE in 1 CARTON (58602-702-09) / 30 TABLET in 1 BOTTLE1 bottle2019-05-030000-00-00NoNoCurrent
58602-702-15586020702151 BOTTLE in 1 CARTON (58602-702-15) / 60 TABLET in 1 BOTTLE1 bottle2018-04-160000-00-00NoNoCurrent
58602-702-17586020702171 BOTTLE in 1 CARTON (58602-702-17) / 45 TABLET in 1 BOTTLE1 bottle2018-04-160000-00-00NoNoCurrent
58602-702-19586020702191 BOTTLE in 1 CARTON (58602-702-19) / 90 TABLET in 1 BOTTLE1 bottle2018-04-160000-00-00NoNoCurrent
58602-702-21586020702211 BOTTLE in 1 CARTON (58602-702-21) / 100 TABLET in 1 BOTTLE1 bottle2019-12-230000-00-00NoNoCurrent
58602-702-23586020702231 BOTTLE in 1 CARTON (58602-702-23) / 120 TABLET in 1 BOTTLE1 bottle2019-10-040000-00-00NoNoCurrent
58602-702-29586020702291 BOTTLE in 1 CARTON (58602-702-29) / 150 TABLET in 1 BOTTLE1 bottle2020-08-130000-00-00NoNoCurrent
58602-702-32586020702321 BOTTLE in 1 CARTON (58602-702-32) / 180 TABLET in 1 BOTTLE1 bottle2018-04-160000-00-00NoNoCurrent
58602-702-38586020702381 BOTTLE in 1 CARTON (58602-702-38) / 300 TABLET in 1 BOTTLE1 bottle2019-05-030000-00-00NoNoCurrent
58602-702-39586020702391 BOTTLE in 1 CARTON (58602-702-39) / 365 TABLET in 1 BOTTLE1 bottle2019-05-030000-00-00NoNoCurrent
58602-702-40586020702401 BOTTLE in 1 CARTON (58602-702-40) / 500 TABLET in 1 BOTTLE1 bottle2019-11-280000-00-00NoNoCurrent
58602-702-44586020702441 BOTTLE in 1 CARTON (58602-702-44) / 400 TABLET in 1 BOTTLE1 bottle2019-07-260000-00-00NoNoCurrent
58602-702-54586020702541 BOTTLE in 1 CARTON (58602-702-54) / 70 TABLET in 1 BOTTLE1 bottle2019-10-040000-00-00NoNoCurrent
58602-702-60586020702601 BLISTER PACK in 1 CARTON (58602-702-60) / 5 TABLET in 1 BLISTER PACK1 blister pack2018-04-160000-00-00NoNoCurrent
58602-702-67586020702672 BLISTER PACK in 1 CARTON (58602-702-67) / 10 TABLET in 1 BLISTER PACK2 blister pack2018-04-160000-00-00NoNoCurrent
58602-702-81586020702811 BOTTLE in 1 CARTON (58602-702-81) / 108 TABLET in 1 BOTTLE1 bottle2018-04-160000-00-00NoNoCurrent
58602-702-83586020702831 BLISTER PACK in 1 CARTON (58602-702-83) / 10 TABLET in 1 BLISTER PACK1 blister pack2018-04-160000-00-00NoNoCurrent
58602-702-84586020702843 BLISTER PACK in 1 CARTON (58602-702-84) / 10 TABLET in 1 BLISTER PACK3 blister pack2018-04-160000-00-00NoNoCurrent