Loratadine

Product NDC
37835-621
11-digit product format
378350621
Labeler code
37835
Product ID
37835-621_327a1a00-8532-2756-e063-6394a90a5e29
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bi-Mart
Application
ANDA210722
Marketing category
ANDA
Marketing start
2020-01-01
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-621-01Loratadine100 in 1 BOTTLETABLET1001
37835-621-10Loratadine10 in 1 BOTTLETABLET101
37835-621-30Loratadine30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-621LORATADINE TABLET [BI-MART]1Current NDC, 3 package rows20250413_1dd299e7-dfdd-459b-bb2b-83e37dd2e63d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN1dd299e7-dfdd-459b-bb2b-83e37dd2e63d1
311372loratadine 10 MG Oral TabletSCD1dd299e7-dfdd-459b-bb2b-83e37dd2e63d1
311372loratadine 10 MG 24 HR Oral TabletSY1dd299e7-dfdd-459b-bb2b-83e37dd2e63d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37835-621-0137835062101100 TABLET in 1 BOTTLE (37835-621-01) 100 tablet2025-03-01NoNoHistorical
37835-621-103783506211010 TABLET in 1 BOTTLE (37835-621-10) 10 tablet2025-03-01NoNoHistorical
37835-621-303783506213030 TABLET in 1 BOTTLE (37835-621-30) 30 tablet2025-03-01NoNoHistorical