FDA.reportPublic FDA data

allergy relief

Product NDC
41163-292
11-digit product format
411630292
Labeler code
41163
Product ID
41163-292_fbe573d6-e133-8c02-e053-6294a90a3f1f
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA211075
Marketing category
ANDA
Marketing start
2021-10-29
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
allergy relief
Listing expiration
2026-12-31

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
41163-292-03allergy relief15 in 1 BLISTER PACKTABLET153
41163-292-03allergy relief1 in 1 CARTONTABLET13
41163-292-04allergy relief1 in 1 CARTONTABLET13
41163-292-04allergy relief30 in 1 BOTTLE, PLASTICTABLET303
41163-292-08allergy relief1 in 1 CARTONTABLET13
41163-292-08allergy relief70 in 1 BOTTLE, PLASTICTABLET703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-292-08EA - Each41163-2922f9c4cec-49f7-4f3c-81bb-c3859efcd7d112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-292ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]3Current NDC, Legacy NDC, 6 package rows20230519_ccff9b0f-8ae5-057f-e053-2a95a90ac2b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNccff9b0f-8ae5-057f-e053-2a95a90ac2b13
997420fexofenadine hydrochloride 180 MG Oral TabletSCDccff9b0f-8ae5-057f-e053-2a95a90ac2b13
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYccff9b0f-8ae5-057f-e053-2a95a90ac2b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-292-03411630292031 BLISTER PACK in 1 CARTON (41163-292-03) / 15 TABLET in 1 BLISTER PACK1 blister pack2021-10-290000-00-00NoNoCurrent
41163-292-04411630292041 BOTTLE, PLASTIC in 1 CARTON (41163-292-04) / 30 TABLET in 1 BOTTLE, PLASTIC2021-10-290000-00-00NoNoCurrent
41163-292-08411630292081 BOTTLE, PLASTIC in 1 CARTON (41163-292-08) / 70 TABLET in 1 BOTTLE, PLASTIC2021-10-290000-00-00NoNoCurrent