FDA.reportPublic FDA data

Children Allergy

Product NDC
0363-2600
11-digit product format
003632600
Labeler code
0363
Product ID
0363-2600_b4975e3b-a036-49da-b220-3bc1d07c5a2b
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreens
Application
ANDA203330
Marketing category
ANDA
Marketing start
2023-10-31
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
Children Allergy

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
0363-2600-04Children Allergy118 mL in 1 BOTTLE, PLASTICSUSPENSION1183
0363-2600-04Children Allergy1 in 1 BOXSUSPENSION13
0363-2600-08Children Allergy237 mL in 1 BOTTLE, PLASTICSUSPENSION2373
0363-2600-08Children Allergy1 in 1 BOXSUSPENSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2600CHILDREN ALLERGY (FEXOFENADINE HCL) SUSPENSION [WALGREENS]2Current NDC, 4 package rows20240224_30517ea8-0a97-4c8f-ad95-739a103784c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSN30517ea8-0a97-4c8f-ad95-739a103784c53
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCD30517ea8-0a97-4c8f-ad95-739a103784c53
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSY30517ea8-0a97-4c8f-ad95-739a103784c53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-2600-04003632600041 BOTTLE, PLASTIC in 1 BOX (0363-2600-04) / 118 mL in 1 BOTTLE, PLASTIC2023-10-312027-03-01NoNoHistorical
0363-2600-08003632600081 BOTTLE, PLASTIC in 1 BOX (0363-2600-08) / 237 mL in 1 BOTTLE, PLASTIC2023-10-312027-03-01NoNoHistorical