FDA.reportPublic FDA data

Childrens Fexofenadine Hydrochloride

Product NDC
51672-2141
11-digit product format
516722141
Labeler code
51672
Product ID
51672-2141_4e3fea44-8570-1aa3-e063-6294a90aa7f5
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA208123
Marketing category
ANDA
Marketing start
2024-01-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Fexofenadine Hydrochloride
Brand name suffix
Allergy
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51672-2141-12026-01-29C16284748780-149896155-a7e6-586f-e063-e6dba90add90Children's Fexofenadine Hcl Allergy
51672-2141-82026-01-29C16284748780-149896155-a7e6-586f-e063-e6dba90add90Children's Fexofenadine Hcl Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2141-1Childrens Fexofenadine HydrochlorideAllergy1 in 1 CARTONSUSPENSION15
51672-2141-1Childrens Fexofenadine HydrochlorideAllergy240 mL in 1 BOTTLESUSPENSION2405
51672-2141-8Childrens Fexofenadine HydrochlorideAllergy120 mL in 1 BOTTLESUSPENSION1205
51672-2141-8Childrens Fexofenadine HydrochlorideAllergy1 in 1 CARTONSUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2141-8ML - Milliliter51672-21417cefccf4-e5bd-46d0-9216-72503db9705012026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2141CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, 4 package rows20240130_b21bb11d-bf74-4ee7-9cfe-5b599a3c4775.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSNb21bb11d-bf74-4ee7-9cfe-5b599a3c47755
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCDb21bb11d-bf74-4ee7-9cfe-5b599a3c47755
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSYb21bb11d-bf74-4ee7-9cfe-5b599a3c47755

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-2141-1516722141011 BOTTLE in 1 CARTON (51672-2141-1) / 240 mL in 1 BOTTLE1 bottle2024-01-24NoNoHistorical
51672-2141-8516722141081 BOTTLE in 1 CARTON (51672-2141-8) / 120 mL in 1 BOTTLE1 bottle2024-01-24NoNoHistorical