Allergy Relief

Product NDC
63868-819
11-digit product format
638680819
Labeler code
63868
Product ID
63868-819_6b2036ce-3522-8d01-7da8-1cfa4082437d
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride 60 mg
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association INC
Application
ANDA076502
Marketing category
ANDA
Marketing start
2021-05-17
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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
FEXOFENADINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-819-12Allergy Relief6 in 1 BLISTER PACKTABLET66
63868-819-12Allergy Relief2 in 1 CARTONTABLET26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-819-12EA - Each63868-819ac9543cb-81c0-4826-b201-29a5d44c24b612022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-819ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE 60 MG) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]5Current NDC, Legacy NDC, 2 package rows20241114_7de8a9b0-9fbc-629e-0fff-2717ec742575.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-819-12638680819122 BLISTER PACK in 1 CARTON (63868-819-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2021-05-170000-00-00NoNoCurrent