FDA.reportPublic FDA data

LORATADINE

Product NDC
69452-283
11-digit product format
694520283
Labeler code
69452
Product ID
69452-283_29f9d1b7-7751-f253-e063-6394a90ac12f
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA202538
Marketing category
ANDA
Marketing start
2020-03-20
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
Rxcui828269

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-283-17LORATADINE60 in 1 BOTTLECAPSULE, LIQUID FILLED605
69452-283-17LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED15
69452-283-19LORATADINE90 in 1 BLISTER PACKCAPSULE, LIQUID FILLED905
69452-283-19LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED15
69452-283-25LORATADINE180 in 1 BOTTLECAPSULE, LIQUID FILLED1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-283LORATADINE CAPSULE, LIQUID FILLED [BIONPHARMA INC.]5Current NDC, Legacy NDC, 5 package rows20241225_4fa705fb-859e-4046-b153-a8338c50a97d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN4fa705fb-859e-4046-b153-a8338c50a97d5
828269loratadine 10 MG Oral CapsuleSCD4fa705fb-859e-4046-b153-a8338c50a97d5
828269loratadine 10 MG 24HR Oral CapsuleSY4fa705fb-859e-4046-b153-a8338c50a97d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-283-17694520283171 BOTTLE in 1 CARTON (69452-283-17) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-08-260000-00-00NoNoCurrent
69452-283-19694520283191 BLISTER PACK in 1 CARTON (69452-283-19) > 90 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2020-03-200000-00-00NoNoCurrent
69452-283-2569452028325180 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-283-25) 2020-03-200000-00-00NoNoCurrent