FDA.reportPublic FDA data

berkley jensen allergy relief

Product NDC
68391-847
11-digit product format
683910847
Labeler code
68391
Product ID
68391-847_fa75f437-073a-439d-8282-d6a60fe2cbcf
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BJWC
Application
ANDA212971
Marketing category
ANDA
Marketing start
2022-02-27
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
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
berkley jensen allergy relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-847-47berkley jensen allergy relief1 in 1 CARTONTABLET, FILM COATED14
68391-847-47berkley jensen allergy relief150 in 1 BOTTLETABLET, FILM COATED1504
68391-847-48berkley jensen allergy relief180 in 1 BOTTLETABLET, FILM COATED1804
68391-847-48berkley jensen allergy relief2 in 1 PACKAGETABLET, FILM COATED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-847BERKLEY JENSEN ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]3Current NDC, Legacy NDC, 4 package rows20250521_2c6d9f8c-bc74-4e1a-bd51-50f84ab63a15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN2c6d9f8c-bc74-4e1a-bd51-50f84ab63a154
997420fexofenadine hydrochloride 180 MG Oral TabletSCD2c6d9f8c-bc74-4e1a-bd51-50f84ab63a154
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY2c6d9f8c-bc74-4e1a-bd51-50f84ab63a154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-847-47683910847471 BOTTLE in 1 CARTON (68391-847-47) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-270000-00-00NoNoCurrent
68391-847-48683910847482 BOTTLE in 1 PACKAGE (68391-847-48) / 180 TABLET, FILM COATED in 1 BOTTLE2 bottle2025-09-04NoNoCurrent