careone allergy relief

Product NDC
72476-847
11-digit product format
724760847
Labeler code
72476
Product ID
72476-847_bc16dd0f-6137-411f-a853-89e616283339
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Retail Business Services, LLC
Application
ANDA212971
Marketing category
ANDA
Marketing start
2021-12-26
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
careone allergy relief
Listing expiration
2027-12-31

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
72476-847-22careone allergy relief15 in 1 CARTONTABLET, FILM COATED153
72476-847-22careone allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED13
72476-847-39careone allergy relief1 in 1 CARTONTABLET, FILM COATED13
72476-847-39careone allergy relief30 in 1 BOTTLETABLET, FILM COATED303
72476-847-95careone allergy relief1 in 1 CARTONTABLET, FILM COATED13
72476-847-95careone allergy relief45 in 1 BOTTLETABLET, FILM COATED453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-847CAREONE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [RETAIL BUSINESS SERVICES, LLC]2Current NDC, Legacy NDC, 6 package rows20220104_ce398856-e9a6-401d-8636-bc5771a7e28b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNce398856-e9a6-401d-8636-bc5771a7e28b3
997420fexofenadine hydrochloride 180 MG Oral TabletSCDce398856-e9a6-401d-8636-bc5771a7e28b3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYce398856-e9a6-401d-8636-bc5771a7e28b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-847-227247608472215 BLISTER PACK in 1 CARTON (72476-847-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2021-12-260000-00-00NoNoCurrent
72476-847-39724760847391 BOTTLE in 1 CARTON (72476-847-39) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-290000-00-00NoNoCurrent
72476-847-95724760847951 BOTTLE in 1 CARTON (72476-847-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-290000-00-00NoNoCurrent