FDA.reportPublic FDA data

Loratadine Allergy Relief

Product NDC
76420-330
11-digit product format
764200330
Labeler code
76420
Product ID
76420-330_359e8af9-0b81-5837-e063-6394a90a58a1
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-330-01Loratadine Allergy Relief100 in 1 BOTTLETABLET1002
76420-330-03Loratadine Allergy Relief300 in 1 BOTTLETABLET3002
76420-330-05Loratadine Allergy Relief500 in 1 BOTTLETABLET5002
76420-330-10Loratadine Allergy Relief10 in 1 BOTTLETABLET102
76420-330-11Loratadine Allergy Relief10 in 1 BLISTER PACKTABLET102
76420-330-20Loratadine Allergy Relief20 in 1 BOTTLETABLET202
76420-330-30Loratadine Allergy Relief30 in 1 BOTTLETABLET302
76420-330-31Loratadine Allergy Relief30 in 1 BLISTER PACKTABLET302
76420-330-60Loratadine Allergy Relief60 in 1 BOTTLETABLET602
76420-330-90Loratadine Allergy Relief90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-330LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [ASCLEMED USA, INC.]2Current NDC, 10 package rows20250523_332bda00-1350-2d33-e063-6394a90a8bd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN332bda00-1350-2d33-e063-6394a90a8bd72
311372loratadine 10 MG Oral TabletSCD332bda00-1350-2d33-e063-6394a90a8bd72
311372loratadine 10 MG 24 HR Oral TabletSY332bda00-1350-2d33-e063-6394a90a8bd72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-330-0176420033001100 TABLET in 1 BOTTLE (76420-330-01) 100 tablet2025-04-19NoNoHistorical
76420-330-0376420033003300 TABLET in 1 BOTTLE (76420-330-03) 300 tablet2025-04-19NoNoHistorical
76420-330-0576420033005500 TABLET in 1 BOTTLE (76420-330-05) 500 tablet2025-04-19NoNoHistorical
76420-330-107642003301010 TABLET in 1 BOTTLE (76420-330-10) 10 tablet2025-04-19NoNoHistorical
76420-330-117642003301110 TABLET in 1 BLISTER PACK (76420-330-11) 10 tablet2025-04-19NoNoHistorical
76420-330-207642003302020 TABLET in 1 BOTTLE (76420-330-20) 20 tablet2025-05-21NoNoHistorical
76420-330-307642003303030 TABLET in 1 BOTTLE (76420-330-30) 30 tablet2025-04-19NoNoHistorical
76420-330-317642003303130 TABLET in 1 BLISTER PACK (76420-330-31) 30 tablet2025-04-19NoNoHistorical
76420-330-607642003306060 TABLET in 1 BOTTLE (76420-330-60) 60 tablet2025-04-19NoNoHistorical
76420-330-907642003309090 TABLET in 1 BOTTLE (76420-330-90) 90 tablet2025-04-19NoNoHistorical