FDA.reportPublic FDA data

Loratadine

Product NDC
68071-3596
11-digit product format
680713596
Labeler code
68071
Product ID
68071-3596_4ece9297-a72e-a420-e063-6394a90ab367
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210722
Marketing category
ANDA
Marketing start
2020-01-01
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine
Listing expiration
2027-12-31

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
68071-3596-3Loratadine30 in 1 BOTTLETABLET303
68071-3596-6Loratadine60 in 1 BOTTLETABLET603
68071-3596-9Loratadine90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3596LORATADINE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 3 package rows20240820_16f00a3a-0777-f70c-e063-6294a90a71c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN16f00a3a-0777-f70c-e063-6294a90a71c93
311372loratadine 10 MG Oral TabletSCD16f00a3a-0777-f70c-e063-6294a90a71c93
311372loratadine 10 MG 24 HR Oral TabletSY16f00a3a-0777-f70c-e063-6294a90a71c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3596-36807135960330 TABLET in 1 BOTTLE (68071-3596-3) 30 tablet2026-04-06NoNoCurrent
68071-3596-66807135960660 TABLET in 1 BOTTLE (68071-3596-6) 60 tablet2024-04-25NoNoCurrent
68071-3596-96807135960990 TABLET in 1 BOTTLE (68071-3596-9) 90 tablet2024-04-25NoNoCurrent