FDA.reportPublic FDA data

Allergy relief

Product NDC
68788-4016
11-digit product format
687884016
Labeler code
68788
Product ID
68788-4016_836f566c-0296-408a-ad2a-6a77e1855218
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075209
Marketing category
ANDA
Marketing start
2025-08-29
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
68788-4016-0Allergy relief10 in 1 BOTTLETABLET101
68788-4016-1Allergy relief14 in 1 BOTTLETABLET141
68788-4016-3Allergy relief30 in 1 BOTTLETABLET301
68788-4016-5Allergy relief15 in 1 BOTTLETABLET151
68788-4016-6Allergy relief60 in 1 BOTTLETABLET601
68788-4016-9Allergy relief90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4016-0EA - Each68788-4016d1b6018b-d39f-4b40-8dc2-2ce24c8a356712025-11-13
68788-4016-1EA - Each68788-40166ba2c117-ca0b-4638-985a-6eb0497b078812025-11-13
68788-4016-3EA - Each68788-40160e238289-dd86-4491-bd97-1b201dd0c77d12025-11-13
68788-4016-5EA - Each68788-4016688887e7-4414-4893-9a42-daa69556597312025-11-13
68788-4016-9EA - Each68788-40162c0bcb79-d958-4de1-8757-030b1077f12112025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN836f566c-0296-408a-ad2a-6a77e18552181
311372loratadine 10 MG Oral TabletSCD836f566c-0296-408a-ad2a-6a77e18552181
311372loratadine 10 MG 24 HR Oral TabletSY836f566c-0296-408a-ad2a-6a77e18552181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4016-06878840160010 TABLET in 1 BOTTLE (68788-4016-0) 10 tablet2025-08-29NoNoHistorical
68788-4016-16878840160114 TABLET in 1 BOTTLE (68788-4016-1) 14 tablet2025-08-29NoNoHistorical
68788-4016-36878840160330 TABLET in 1 BOTTLE (68788-4016-3) 30 tablet2025-08-29NoNoHistorical
68788-4016-56878840160515 TABLET in 1 BOTTLE (68788-4016-5) 15 tablet2025-08-29NoNoHistorical
68788-4016-66878840160660 TABLET in 1 BOTTLE (68788-4016-6) 60 tablet2025-08-29NoNoHistorical
68788-4016-96878840160990 TABLET in 1 BOTTLE (68788-4016-9) 90 tablet2025-08-29NoNoHistorical