FDA.reportPublic FDA data

Fexofenadine HCl and Pseudoephedrine HCI

Product NDC
0363-1606
11-digit product format
003631606
Labeler code
0363
Product ID
0363-1606_22a37aee-5811-616b-a794-4c24bd940d73
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Walgreens Company
Application
ANDA076667
Marketing category
ANDA
Marketing start
2019-09-16
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 HCl and Pseudoephedrine HCI
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1606-20Fexofenadine HCl and Pseudoephedrine HCI5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE52
0363-1606-20Fexofenadine HCl and Pseudoephedrine HCI4 in 1 CARTONTABLET, EXTENDED RELEASE42
0363-1606-30Fexofenadine HCl and Pseudoephedrine HCI6 in 1 CARTONTABLET, EXTENDED RELEASE62
0363-1606-30Fexofenadine HCl and Pseudoephedrine HCI5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE52

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1606FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]2Current NDC, Legacy NDC, 4 package rows20190916_37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997406fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b32
99740612 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b32
997406fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1606-20003631606204 BLISTER PACK in 1 CARTON (0363-1606-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2019-09-160000-00-00NoNoCurrent
0363-1606-30003631606306 BLISTER PACK in 1 CARTON (0363-1606-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2019-09-160000-00-00NoNoCurrent