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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079043-002FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2011-06-22

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCl and Pseudoephedrine HClFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCLWalmart Inc.883d21cd-4c5f-b502-1465-e346ecc2e2ec2025-07-22WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have difficulty swallowing Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions). Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

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