FDA.reportPublic FDA data

Fexofenadine HCl and Pseudoephedrine HCl

Product NDC
79903-255
11-digit product format
799030255
Labeler code
79903
Product ID
79903-255_83a5d9eb-bd3e-cc54-e27d-0271a3391d2c
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Walmart Inc.
Application
ANDA079043
Marketing category
ANDA
Marketing start
2022-11-30
Marketing end
2026-08-31
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
180; 240 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine HCl and Pseudoephedrine HCl

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU, 6V9V2RYJ8N
Rxcui997415

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-255-05Fexofenadine HCl and Pseudoephedrine HCl5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE54
79903-255-10Fexofenadine HCl and Pseudoephedrine HCl2 in 1 CARTONTABLET, EXTENDED RELEASE24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-255FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [WALMART INC.]3Current NDC, 2 package rows20240411_883d21cd-4c5f-b502-1465-e346ecc2e2ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997415fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral TabletPSN883d21cd-4c5f-b502-1465-e346ecc2e2ec4
99741524 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral TabletSCD883d21cd-4c5f-b502-1465-e346ecc2e2ec4
997415fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral TabletSY883d21cd-4c5f-b502-1465-e346ecc2e2ec4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79903-255-05799030255055 in 1 BLISTER PACKHistorical
79903-255-10799030255102 BLISTER PACK in 1 CARTON (79903-255-10) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (79903-255-05) 2 blister pack2024-09-012026-08-31NoNoHistorical