FDA.reportPublic FDA data

Childrens Allergy

Product NDC
61269-527
11-digit product format
612690527
Labeler code
61269
Product ID
61269-527_33920aab-2fdc-44ed-b36d-0d759a9bcd94
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
SUSPENSION
Route
ORAL
Labeler
H2-Pharma, LLC
Application
ANDA203330
Marketing category
ANDA
Marketing start
2022-07-18
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 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
61269-527-94Childrens Allergy1 in 1 CARTONSUSPENSION13
61269-527-94Childrens Allergy118 mL in 1 BOTTLESUSPENSION1183
61269-527-98Childrens Allergy237 mL in 1 BOTTLESUSPENSION2373
61269-527-98Childrens Allergy1 in 1 CARTONSUSPENSION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-527-94ML - Milliliter61269-527a2d29eb1-9492-44c9-b219-aae86193862512022-08-04
61269-527-98ML - Milliliter61269-527ff459bbc-d620-437e-997e-8337e0120ad812022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-527CHILDRENS ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [H2-PHARMA, LLC]2Current NDC, Legacy NDC, 4 package rows20250413_84988f6d-85b1-45dd-89be-0333acc6b180.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSN84988f6d-85b1-45dd-89be-0333acc6b1803
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCD84988f6d-85b1-45dd-89be-0333acc6b1803
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSY84988f6d-85b1-45dd-89be-0333acc6b1803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61269-527-94612690527941 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLE1 bottle2022-07-180000-00-00NoNoCurrent
61269-527-98612690527981 BOTTLE in 1 CARTON (61269-527-98) > 237 mL in 1 BOTTLE1 bottle2022-07-180000-00-00NoNoCurrent