FDA.reportPublic FDA data

Childrens Fexofenadine Hydrochloride

Product NDC
0363-2141
11-digit product format
003632141
Labeler code
0363
Product ID
0363-2141_374f99cb-1562-7532-e063-6394a90a95b4
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreens Company
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2141-01Childrens Fexofenadine HydrochlorideAllergy240 mL in 1 BOTTLESUSPENSION2401
0363-2141-01Childrens Fexofenadine HydrochlorideAllergy1 in 1 CARTONSUSPENSION11
0363-2141-08Childrens Fexofenadine HydrochlorideAllergy120 mL in 1 BOTTLESUSPENSION1201
0363-2141-08Childrens Fexofenadine HydrochlorideAllergy1 in 1 CARTONSUSPENSION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSN374f9271-b65b-69a9-e063-6394a90af36a1
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCD374f9271-b65b-69a9-e063-6394a90af36a1
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSY374f9271-b65b-69a9-e063-6394a90af36a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-2141-01003632141011 BOTTLE in 1 CARTON (0363-2141-01) / 240 mL in 1 BOTTLE1 bottle2024-12-06NoNoHistorical
0363-2141-08003632141081 BOTTLE in 1 CARTON (0363-2141-08) / 120 mL in 1 BOTTLE1 bottle2024-12-06NoNoHistorical