FDA.reportPublic FDA data

Loratadine

Product NDC
71335-2391
11-digit product format
713352391
Labeler code
71335
Product ID
71335-2391_18eab889-2148-4233-aca0-38b185d5934d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211718
Marketing category
ANDA
Marketing start
2023-07-28
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
71335-2391-1Loratadine20 in 1 BOTTLETABLET201
71335-2391-2Loratadine30 in 1 BOTTLETABLET301
71335-2391-3Loratadine60 in 1 BOTTLETABLET601
71335-2391-4Loratadine14 in 1 BOTTLETABLET141
71335-2391-5Loratadine10 in 1 BOTTLETABLET101
71335-2391-6Loratadine90 in 1 BOTTLETABLET901
71335-2391-7Loratadine28 in 1 BOTTLETABLET281
71335-2391-8Loratadine15 in 1 BOTTLETABLET151
71335-2391-9Loratadine100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2391-1EA - Each71335-23914fc06ac6-23bc-471d-bbdf-1cbf50ce3e2c12026-01-08
71335-2391-2EA - Each71335-23916c035bd3-b72c-40ef-9462-42dc3e65c1a812025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNbaad51cd-daa0-4920-a6d5-2faaaaea79561
311372loratadine 10 MG Oral TabletSCDbaad51cd-daa0-4920-a6d5-2faaaaea79561
311372loratadine 10 MG 24 HR Oral TabletSYbaad51cd-daa0-4920-a6d5-2faaaaea79561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2391-17133523910120 TABLET in 1 BOTTLE (71335-2391-1) 20 tablet2025-06-18NoNoHistorical
71335-2391-27133523910230 TABLET in 1 BOTTLE (71335-2391-2) 30 tablet2025-06-18NoNoHistorical
71335-2391-37133523910360 TABLET in 1 BOTTLE (71335-2391-3) 60 tablet2025-06-18NoNoHistorical
71335-2391-47133523910414 TABLET in 1 BOTTLE (71335-2391-4) 14 tablet2025-06-18NoNoHistorical
71335-2391-57133523910510 TABLET in 1 BOTTLE (71335-2391-5) 10 tablet2025-06-18NoNoHistorical
71335-2391-67133523910690 TABLET in 1 BOTTLE (71335-2391-6) 90 tablet2025-06-18NoNoHistorical
71335-2391-77133523910728 TABLET in 1 BOTTLE (71335-2391-7) 28 tablet2025-06-18NoNoHistorical
71335-2391-87133523910815 TABLET in 1 BOTTLE (71335-2391-8) 15 tablet2025-06-18NoNoHistorical
71335-2391-971335239109100 TABLET in 1 BOTTLE (71335-2391-9) 100 tablet2025-06-18NoNoHistorical