FDA.reportPublic FDA data

Dye Free Wal Fex

Product NDC
0363-9230
11-digit product format
003639230
Labeler code
0363
Product ID
0363-9230_97aafbd4-7cc5-43f3-82cb-8799f8360862
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreens
Application
ANDA203330
Marketing category
ANDA
Marketing start
2020-06-01
Marketing end
2027-03-01
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
30 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dye Free Wal Fex
Brand name suffix
childrens allergy

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997491, 1670344

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
0363-9230-04Dye Free Wal Fexchildrens allergy118 mL in 1 BOTTLE, PLASTICSUSPENSION1188
0363-9230-04Dye Free Wal Fexchildrens allergy1 in 1 BOXSUSPENSION18
0363-9230-08Dye Free Wal Fexchildrens allergy237 mL in 1 BOTTLE, PLASTICSUSPENSION2378
0363-9230-08Dye Free Wal Fexchildrens allergy1 in 1 BOXSUSPENSION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9230DYE FREE WAL FEX CHILDRENS ALLERGY (FEXOFENADINE HCL) SUSPENSION [WALGREENS]7Current NDC, Legacy NDC, 4 package rows20220626_9062c258-4c3e-412d-a31f-1e748a67513f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSN9062c258-4c3e-412d-a31f-1e748a67513f8
1670344Wal-Fex 30 MG in 5 mL Oral SuspensionPSN9062c258-4c3e-412d-a31f-1e748a67513f8
1670344fexofenadine hydrochloride 6 MG/ML Oral Suspension [Wal-Fex]SBD9062c258-4c3e-412d-a31f-1e748a67513f8
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCD9062c258-4c3e-412d-a31f-1e748a67513f8
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSY9062c258-4c3e-412d-a31f-1e748a67513f8
1670344Wal-Fex 30 MG per 5 ML Oral SuspensionSY9062c258-4c3e-412d-a31f-1e748a67513f8
1670344Wal-Fex 6 MG/ML Oral SuspensionSY9062c258-4c3e-412d-a31f-1e748a67513f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9230-04003639230041 BOTTLE, PLASTIC in 1 BOX (0363-9230-04) / 118 mL in 1 BOTTLE, PLASTIC2020-06-012027-03-01NoNoCurrent
0363-9230-08003639230081 BOTTLE, PLASTIC in 1 BOX (0363-9230-08) / 237 mL in 1 BOTTLE, PLASTIC2020-06-012027-03-01NoNoCurrent