Childrens Allergy

Product NDC
49035-208
11-digit product format
490350208
Labeler code
49035
Product ID
49035-208_b407f021-be2e-4c6e-aef6-583778b4681b
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
SUSPENSION
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
ANDA203330
Marketing category
ANDA
Marketing start
2020-07-01
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
30 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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
49035-208-04Childrens Allergy1 in 1 CARTONSUSPENSION14
49035-208-04Childrens Allergy118 mL in 1 BOTTLE, PLASTICSUSPENSION1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-208CHILDRENS ALLERGY (FEXOFENADINE HCL) SUSPENSION [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]4Current NDC, Legacy NDC, 2 package rows20231012_667c87c2-c594-49e5-92a7-f8aa140642d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSN667c87c2-c594-49e5-92a7-f8aa140642d64
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCD667c87c2-c594-49e5-92a7-f8aa140642d64
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSY667c87c2-c594-49e5-92a7-f8aa140642d64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-208-04490350208041 BOTTLE, PLASTIC in 1 CARTON (49035-208-04) / 118 mL in 1 BOTTLE, PLASTIC2020-07-010000-00-00NoNoCurrent