FDA.reportPublic FDA data

Allegra Hives 24hr

Product NDC
41167-4126
11-digit product format
411674126
Labeler code
41167
Product ID
41167-4126_942f38c8-c652-49b9-b98f-e8edcf66db1c
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA020872
Marketing category
NDA
Marketing start
2022-06-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allegra Hives 24hr
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420, 997422

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
41167-4126-3Allegra Hives 24hr15 in 1 BOTTLETABLET, FILM COATED1510
41167-4126-3Allegra Hives 24hr1 in 1 CARTONTABLET, FILM COATED110
41167-4126-4Allegra Hives 24hr1 in 1 CARTONTABLET, FILM COATED110
41167-4126-4Allegra Hives 24hr30 in 1 BOTTLETABLET, FILM COATED3010
41167-4126-8Allegra Hives 24hr1 in 1 CARTONTABLET, FILM COATED110
41167-4126-8Allegra Hives 24hr5 in 1 BLISTER PACKTABLET, FILM COATED510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4126ALLEGRA HIVES 24HR (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.]9Current NDC, Legacy NDC, 6 package rows20241127_490b4c5f-448b-4563-928b-837117b59b9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997422Allegra 180 MG Oral TabletPSN490b4c5f-448b-4563-928b-837117b59b9f10
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN490b4c5f-448b-4563-928b-837117b59b9f10
997422fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]SBD490b4c5f-448b-4563-928b-837117b59b9f10
997420fexofenadine hydrochloride 180 MG Oral TabletSCD490b4c5f-448b-4563-928b-837117b59b9f10
997422Allegra 180 MG Oral TabletSY490b4c5f-448b-4563-928b-837117b59b9f10
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY490b4c5f-448b-4563-928b-837117b59b9f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-4126-3411674126031 BOTTLE in 1 CARTON (41167-4126-3) / 15 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-310000-00-00NoNoCurrent
41167-4126-4411674126041 BOTTLE in 1 CARTON (41167-4126-4) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-060000-00-00NoNoCurrent
41167-4126-8411674126081 BLISTER PACK in 1 CARTON (41167-4126-8) / 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-06-060000-00-00NoNoCurrent