XL - 3 Allergy

Product NDC
63654-415
11-digit product format
636540415
Labeler code
63654
Product ID
63654-415_928e4434-6c15-4bf1-bcfd-1f56a17510ed
Type
HUMAN OTC DRUG
Nonproprietary name
XL - 3 Allergy
Dosage form
TABLET
Route
ORAL
Labeler
Selder, S.A. de C.V.
Application
ANDA210722
Marketing category
ANDA
Marketing start
2024-04-10
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
XL - 3 Allergy
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
63654-415-10XL - 3 Allergy1 in 1 CARTONTABLET11
63654-415-10XL - 3 Allergy10 in 1 BLISTER PACKTABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63654-415XL - 3 ALLERGY TABLET [SELDER, S.A. DE C.V.]1Current NDC, 2 package rows20240412_059a6e72-888e-4cb3-8722-4c3acbd6b4b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN059a6e72-888e-4cb3-8722-4c3acbd6b4b01
311372loratadine 10 MG Oral TabletSCD059a6e72-888e-4cb3-8722-4c3acbd6b4b01
311372loratadine 10 MG 24 HR Oral TabletSY059a6e72-888e-4cb3-8722-4c3acbd6b4b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63654-415-10636540415101 BLISTER PACK in 1 CARTON (63654-415-10) / 10 TABLET in 1 BLISTER PACK1 blister pack2024-04-10NoNoHistorical