FDA.reportPublic FDA data

Fexofenadine HCl and Pseudoephedrine HCI

Product NDC
55111-557
11-digit product format
551110557
Labeler code
55111
Product ID
55111-557_29216032-68a5-566a-5eaf-ffc9cb597e9a
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA079043
Marketing category
ANDA
Marketing start
2011-08-24
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
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 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
55111-557-07Fexofenadine HCl and Pseudoephedrine HCI1 in 1 CARTONTABLET, EXTENDED RELEASE19
55111-557-07Fexofenadine HCl and Pseudoephedrine HCI5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE59
55111-557-29Fexofenadine HCl and Pseudoephedrine HCI3 in 1 CARTONTABLET, EXTENDED RELEASE39
55111-557-29Fexofenadine HCl and Pseudoephedrine HCI5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE59
55111-557-35Fexofenadine HCl and Pseudoephedrine HCI2 in 1 CARTONTABLET, EXTENDED RELEASE29
55111-557-35Fexofenadine HCl and Pseudoephedrine HCI5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-557-35EA - Each55111-55776ad12b8-9c8a-4a98-948b-6f768d9c287812021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]5
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-557FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]9Current NDC, Legacy NDC, 6 package rows20181211_25cca459-fdd6-3847-2207-dd4f019781b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997415fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral TabletPSN25cca459-fdd6-3847-2207-dd4f019781b59
99741524 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral TabletSCD25cca459-fdd6-3847-2207-dd4f019781b59
997415fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral TabletSY25cca459-fdd6-3847-2207-dd4f019781b59
997415fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral TabletPSN65a92250-d0e8-c902-b14c-67f53ab266351
99741524 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral TabletSCD65a92250-d0e8-c902-b14c-67f53ab266351
997415fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral TabletSY65a92250-d0e8-c902-b14c-67f53ab266351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-557-07551110557071 BLISTER PACK in 1 CARTON (55111-557-07) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2011-08-240000-00-00NoNoCurrent
55111-557-29551110557293 BLISTER PACK in 1 CARTON (55111-557-29) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2011-08-240000-00-00NoNoCurrent
55111-557-35551110557352 BLISTER PACK in 1 CARTON (55111-557-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2011-08-240000-00-00NoNoCurrent