FDA.reportPublic FDA data

Childrens Fexofenadine Hydrochloride

Product NDC
79903-306
11-digit product format
799030306
Labeler code
79903
Product ID
79903-306_2905c49e-1ab8-3d84-e063-6394a90ac1a4
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA208123
Marketing category
ANDA
Marketing start
2024-12-06
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
30 mg/5mL
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
Childrens Fexofenadine Hydrochloride
Brand name suffix
Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997491

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-306-04Childrens Fexofenadine HydrochlorideAllergy120 mL in 1 BOTTLESUSPENSION1202
79903-306-04Childrens Fexofenadine HydrochlorideAllergy1 in 1 CARTONSUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-306CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [WAL-MART STORES INC]2Current NDC, 2 package rows20241222_2432f862-6d7e-666d-e063-6294a90acf74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSN2432f862-6d7e-666d-e063-6294a90acf742
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCD2432f862-6d7e-666d-e063-6294a90acf742
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSY2432f862-6d7e-666d-e063-6294a90acf742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-306-04799030306041 BOTTLE in 1 CARTON (79903-306-04) / 120 mL in 1 BOTTLE1 bottle2024-12-06NoNoCurrent