FDA.reportPublic FDA data

allergy relief

Product NDC
0363-1612
11-digit product format
003631612
Labeler code
0363
Product ID
0363-1612_511ca689-d11e-4aeb-b55d-a2d01e20060a
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Walgreen Company
Application
ANDA076301
Marketing category
ANDA
Marketing start
2021-10-21
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
allergy relief
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
0363-1612-03allergy relief70 in 1 BOTTLETABLET706
0363-1612-03allergy relief1 in 1 CARTONTABLET16
0363-1612-46allergy relief10 in 1 CARTONTABLET106
0363-1612-46allergy relief1 in 1 BLISTER PACKTABLET16
0363-1612-47allergy relief150 in 1 BOTTLETABLET1506
0363-1612-47allergy relief1 in 1 CARTONTABLET16
0363-1612-58allergy relief40 in 1 BOTTLETABLET406
0363-1612-58allergy relief1 in 1 CARTONTABLET16
0363-1612-60allergy relief20 in 1 CARTONTABLET206
0363-1612-60allergy relief1 in 1 BLISTER PACKTABLET16
0363-1612-65allergy relief1 in 1 CARTONTABLET16
0363-1612-65allergy relief30 in 1 BOTTLETABLET306
0363-1612-75allergy relief1 in 1 CARTONTABLET16
0363-1612-75allergy relief90 in 1 BOTTLETABLET906
0363-1612-78allergy relief1 in 1 CARTONTABLET16
0363-1612-78allergy relief100 in 1 BOTTLETABLET1006
0363-1612-88allergy relief365 in 1 BOTTLETABLET3656
0363-1612-88allergy relief1 in 1 CARTONTABLET16
0363-1612-95allergy relief1 in 1 CARTONTABLET16
0363-1612-95allergy relief45 in 1 BOTTLETABLET456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1612ALLERGY RELIEF (LORATADINE) TABLET [WALGREEN COMPANY]6Current NDC, Legacy NDC, 20 package rows20250403_41f8fc1d-2d14-48da-a233-23e9c11296d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN41f8fc1d-2d14-48da-a233-23e9c11296d96
311372loratadine 10 MG Oral TabletSCD41f8fc1d-2d14-48da-a233-23e9c11296d96
311372loratadine 10 MG 24 HR Oral TabletSY41f8fc1d-2d14-48da-a233-23e9c11296d96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1612-03003631612031 BOTTLE in 1 CARTON (0363-1612-03) / 70 TABLET in 1 BOTTLE1 bottle2022-04-040000-00-00NoNoCurrent
0363-1612-460036316124610 BLISTER PACK in 1 CARTON (0363-1612-46) > 1 TABLET in 1 BLISTER PACK10 blister pack2021-10-210000-00-00NoNoCurrent
0363-1612-47003631612471 BOTTLE in 1 CARTON (0363-1612-47) / 150 TABLET in 1 BOTTLE1 bottle2021-10-210000-00-00NoNoCurrent
0363-1612-58003631612581 BOTTLE in 1 CARTON (0363-1612-58) / 40 TABLET in 1 BOTTLE1 bottle2024-12-10NoNoHistorical
0363-1612-600036316126020 BLISTER PACK in 1 CARTON (0363-1612-60) > 1 TABLET in 1 BLISTER PACK20 blister pack2021-10-210000-00-00NoNoCurrent
0363-1612-65003631612651 BOTTLE in 1 CARTON (0363-1612-65) / 30 TABLET in 1 BOTTLE1 bottle2021-10-210000-00-00NoNoCurrent
0363-1612-75003631612751 BOTTLE in 1 CARTON (0363-1612-75) / 90 TABLET in 1 BOTTLE1 bottle2021-12-070000-00-00NoNoCurrent
0363-1612-78003631612781 BOTTLE in 1 CARTON (0363-1612-78) / 100 TABLET in 1 BOTTLE1 bottle2024-12-10NoNoHistorical
0363-1612-88003631612881 BOTTLE in 1 CARTON (0363-1612-88) / 365 TABLET in 1 BOTTLE1 bottle2022-03-080000-00-00NoNoCurrent
0363-1612-95003631612951 BOTTLE in 1 CARTON (0363-1612-95) / 45 TABLET in 1 BOTTLE1 bottle2024-08-23NoNoHistorical