FDA.reportPublic FDA data

Alavert

Product NDC
69536-195
11-digit product format
695360195
Labeler code
69536
Product ID
69536-195_1ba62e9b-1b1f-016a-e063-6394a90a065e
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Foundation Consumer Healthcare
Application
ANDA213294
Marketing category
ANDA
Marketing start
2024-10-31
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
Alavert
Brand name suffix
Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311373, 351855

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-195-20AlavertAllergy1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
69536-195-20AlavertAllergy20 in 1 CARTONTABLET, ORALLY DISINTEGRATING202
69536-195-60AlavertAllergy1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
69536-195-60AlavertAllergy60 in 1 CARTONTABLET, ORALLY DISINTEGRATING602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-195ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [FOUNDATION CONSUMER HEALTHCARE]2Current NDC, 4 package rows20241101_1704474a-9b99-de45-e063-6294a90ac59b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351855Alavert 10 MG 24HR Disintegrating Oral TabletPSN1704474a-9b99-de45-e063-6294a90ac59b2
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN1704474a-9b99-de45-e063-6294a90ac59b2
351855loratadine 10 MG Disintegrating Oral Tablet [Alavert]SBD1704474a-9b99-de45-e063-6294a90ac59b2
311373loratadine 10 MG Disintegrating Oral TabletSCD1704474a-9b99-de45-e063-6294a90ac59b2
35185524 HR Alavert 10 MG Disintegrating Oral TabletSY1704474a-9b99-de45-e063-6294a90ac59b2
351855Alavert 10 MG Disintegrating Oral TabletSY1704474a-9b99-de45-e063-6294a90ac59b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69536-195-206953601952020 BLISTER PACK in 1 CARTON (69536-195-20) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK20 blister pack2024-10-31NoNoCurrent
69536-195-606953601956060 BLISTER PACK in 1 CARTON (69536-195-60) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK60 blister pack2024-10-31NoNoCurrent