FDA.reportPublic FDA data

Allergy Relief

Product NDC
63548-0663
11-digit product format
635480663
Labeler code
63548
Product ID
63548-0663_12832954-b355-49a3-9f33-7cc163d16298
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application
ANDA204097
Marketing category
ANDA
Marketing start
2019-10-01
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
Rxcui997501

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63548-0663-52023-02-09C16284748780-1f386c649-fb6e-0266-e053-dadaa90a7c1aDRUG FACTS
63548-0663-52023-01-30C16284748780-1f386c649-fb6e-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63548-0663-5Allergy Relief500 in 1 BOTTLE, PLASTICTABLET, COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63548-0663ALLERGY RELIEF (FEXOFENADINE HCL) TABLET, COATED [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20230210_0c83f650-f2bf-4c5b-a1e3-7c40cd9c4c6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSN0c83f650-f2bf-4c5b-a1e3-7c40cd9c4c6f3
997501fexofenadine hydrochloride 60 MG Oral TabletSCD0c83f650-f2bf-4c5b-a1e3-7c40cd9c4c6f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63548-0663-563548066305500 TABLET, COATED in 1 BOTTLE, PLASTIC (63548-0663-5) 2019-10-010000-00-00NoNoCurrent