FDA.reportPublic FDA data

Fexofenadine HCl and Pseudoephedrine HCI

Product NDC
30142-611
11-digit product format
301420611
Labeler code
30142
Product ID
30142-611_29c914f7-dfd8-2f34-2cab-9a239e6c58a9
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
The Kroger Co.
Application
ANDA076667
Marketing category
ANDA
Marketing start
2019-01-15
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
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
30142-611-14Fexofenadine HCl and Pseudoephedrine HCI5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE52
30142-611-14Fexofenadine HCl and Pseudoephedrine HCI4 in 1 CARTONTABLET, EXTENDED RELEASE42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-611FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.]2Current NDC, Legacy NDC, 2 package rows20190612_8cf0b878-ec13-fd44-d56f-f44af7c249ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997406fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN8cf0b878-ec13-fd44-d56f-f44af7c249ed2
99740612 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD8cf0b878-ec13-fd44-d56f-f44af7c249ed2
997406fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY8cf0b878-ec13-fd44-d56f-f44af7c249ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-611-14301420611144 BLISTER PACK in 1 CARTON (30142-611-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2019-01-150000-00-00NoNoCurrent