Allergy Relief

Product NDC
63548-0664
11-digit product format
635480664
Labeler code
63548
Product ID
63548-0664_df845ee9-b17a-484f-be90-1918450c6b75
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
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
180 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 HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63548-0664-52023-02-09C16284748780-1f386c649-f109-0266-e053-dadaa90a7c1aDRUG FACTS
63548-0664-52023-01-30C16284748780-1f386c649-f109-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63548-0664-5Allergy Relief500 in 1 BOTTLE, PLASTICTABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63548-0664ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS]2Current NDC, Legacy NDC, 1 package rows20230210_9f1f292d-6d5f-4600-ad27-323e498ddecb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN9f1f292d-6d5f-4600-ad27-323e498ddecb2
997420fexofenadine hydrochloride 180 MG Oral TabletSCD9f1f292d-6d5f-4600-ad27-323e498ddecb2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY9f1f292d-6d5f-4600-ad27-323e498ddecb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63548-0664-563548066405500 TABLET in 1 BOTTLE, PLASTIC (63548-0664-5) 500 tablet2019-10-010000-00-00NoNoCurrent