Childrens Allergy

Product NDC
37808-623
11-digit product format
378080623
Labeler code
37808
Product ID
37808-623_8a5fcd6f-fb2c-4c81-ba1c-ad5b3cf87ad0
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
SUSPENSION
Route
ORAL
Labeler
H E B
Application
ANDA203330
Marketing category
ANDA
Marketing start
2021-04-30
Marketing end
2027-08-31
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
Childrens 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
37808-623-04Childrens Allergy118 mL in 1 BOTTLE, PLASTICSUSPENSION1183
37808-623-04Childrens Allergy1 in 1 CARTONSUSPENSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-623CHILDRENS ALLERGY (FEXOFENADINE HCL) SUSPENSION [H E B]2Current NDC, Legacy NDC, 2 package rows20230608_3b6f4a4b-b1bd-4062-9e7f-571b836b1536.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSN3b6f4a4b-b1bd-4062-9e7f-571b836b15363
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCD3b6f4a4b-b1bd-4062-9e7f-571b836b15363
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSY3b6f4a4b-b1bd-4062-9e7f-571b836b15363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-623-04378080623041 BOTTLE, PLASTIC in 1 CARTON (37808-623-04) / 118 mL in 1 BOTTLE, PLASTIC2021-04-302027-08-31NoNoCurrent