Loratadine Allergy Relief

Product NDC
37808-529
11-digit product format
378080529
Labeler code
37808
Product ID
37808-529_c624b449-9db2-4b2e-852f-28f745aa7e2a
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
HEB
Application
ANDA076134
Marketing category
ANDA
Marketing start
2018-02-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-529-01Loratadine Allergy Relief100 in 1 BOTTLETABLET1001
37808-529-11Loratadine Allergy Relief10 in 1 BLISTER PACKTABLET101
37808-529-11Loratadine Allergy Relief1 in 1 CARTONTABLET11
37808-529-31Loratadine Allergy Relief30 in 1 CARTONTABLET301
37808-529-31Loratadine Allergy Relief1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-529LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [HEB]1Current NDC, Legacy NDC, 5 package rows20180518_6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda1
311372loratadine 10 MG Oral TabletSCD6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda1
311372loratadine 10 MG 24 HR Oral TabletSY6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-529-0137808052901100 TABLET in 1 BOTTLE (37808-529-01) 100 tablet2018-02-010000-00-00NoNoCurrent
37808-529-11378080529111 BLISTER PACK in 1 CARTON (37808-529-11) / 10 TABLET in 1 BLISTER PACK1 blister pack2018-02-010000-00-00NoNoCurrent
37808-529-313780805293130 BLISTER PACK in 1 CARTON (37808-529-31) / 1 TABLET in 1 BLISTER PACK30 blister pack2018-02-010000-00-00NoNoCurrent