FDA.reportPublic FDA data

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Product NDC
47335-724
11-digit product format
473350724
Labeler code
47335
Product ID
47335-724_554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090818
Marketing category
ANDA
Marketing start
2018-03-01
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60; 120 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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU, 6V9V2RYJ8N
Rxcui997406

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
47335-724-60Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride5 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE513
47335-724-64Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride6 in 1 CARTONTABLET, FILM COATED, EXTENDED RE613
47335-724-66Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE213
47335-724-75Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride4 in 1 CARTONTABLET, FILM COATED, EXTENDED RE413
47335-724-83Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3013
47335-724-94Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE113
47335-724-94Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE1013
47335-724-95Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride3 in 1 CARTONTABLET, FILM COATED, EXTENDED RE313
47335-724-95Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE1013
47335-724-99Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE213
47335-724-99Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE1013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-724FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 11 package rows20250312_8afc0167-17bf-4ccd-91c9-8fb9c4e241c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997406fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN8afc0167-17bf-4ccd-91c9-8fb9c4e241c113
99740612 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD8afc0167-17bf-4ccd-91c9-8fb9c4e241c113
997406fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY8afc0167-17bf-4ccd-91c9-8fb9c4e241c113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-724-60473350724605 in 1 BLISTER PACKHistorical
47335-724-64473350724646 BLISTER PACK in 1 CARTON (47335-724-64) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) 6 blister pack2018-03-010000-00-00NoNoCurrent
47335-724-66473350724662 BLISTER PACK in 1 CARTON (47335-724-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) 2 blister pack2018-03-010000-00-00NoNoCurrent
47335-724-75473350724754 BLISTER PACK in 1 CARTON (47335-724-75) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) 4 blister pack2018-03-010000-00-00NoNoCurrent
47335-724-834733507248330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-724-83) 2018-03-010000-00-00NoNoCurrent
47335-724-94473350724941 BLISTER PACK in 1 CARTON (47335-724-94) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2018-03-010000-00-00NoNoCurrent
47335-724-95473350724953 BLISTER PACK in 1 CARTON (47335-724-95) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2018-03-010000-00-00NoNoCurrent
47335-724-99473350724992 BLISTER PACK in 1 CARTON (47335-724-99) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2018-03-010000-00-00NoNoCurrent