FDA.reportPublic FDA data

Allergy Relief

Product NDC
57344-292
11-digit product format
573440292
Labeler code
57344
Product ID
57344-292_1e038697-ba15-dca2-e063-6394a90a0bee
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AAA PHARMACEUTICAL, INC.
Application
ANDA211075
Marketing category
ANDA
Marketing start
2021-07-06
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57344-292-02Allergy Relief5 in 1 BLISTER PACKTABLET55
57344-292-02Allergy Relief1 in 1 CARTONTABLET15
57344-292-03Allergy Relief1 in 1 CARTONTABLET15
57344-292-03Allergy Relief5 in 1 BLISTER PACKTABLET55
57344-292-04Allergy Relief1 in 1 CARTONTABLET15
57344-292-04Allergy Relief30 in 1 BOTTLE, PLASTICTABLET305
57344-292-06Allergy Relief45 in 1 BOTTLE, PLASTICTABLET455
57344-292-06Allergy Relief1 in 1 CARTONTABLET15
57344-292-17Allergy Relief1 in 1 CARTONTABLET15
57344-292-17Allergy Relief30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57344-292ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [AAA PHARMACEUTICAL, INC.]5Current NDC, Legacy NDC, 10 package rows20240725_c547c163-2a19-10d8-e053-2a95a90ac817.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNc547c163-2a19-10d8-e053-2a95a90ac8175
997420fexofenadine hydrochloride 180 MG Oral TabletSCDc547c163-2a19-10d8-e053-2a95a90ac8175
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYc547c163-2a19-10d8-e053-2a95a90ac8175

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57344-292-02573440292021 BLISTER PACK in 1 CARTON (57344-292-02) / 5 TABLET in 1 BLISTER PACK1 blister pack2021-07-060000-00-00NoNoCurrent
57344-292-03573440292031 BLISTER PACK in 1 CARTON (57344-292-03) / 5 TABLET in 1 BLISTER PACK1 blister pack2021-07-060000-00-00NoNoCurrent
57344-292-04573440292041 BOTTLE, PLASTIC in 1 CARTON (57344-292-04) / 30 TABLET in 1 BOTTLE, PLASTIC2021-07-060000-00-00NoNoCurrent
57344-292-06573440292061 BOTTLE, PLASTIC in 1 CARTON (57344-292-06) / 45 TABLET in 1 BOTTLE, PLASTIC2021-07-060000-00-00NoNoCurrent
57344-292-17573440292171 BOTTLE, PLASTIC in 1 CARTON (57344-292-17) / 30 TABLET in 1 BOTTLE, PLASTIC2024-07-24NoNoHistorical