Fexofenadine HCl and Pseudoephedrine HCl

Product NDC
11822-0007
11-digit product format
118220007
Labeler code
11822
Product ID
11822-0007_ee610aaa-d53f-2dbc-548f-71973b2c1406
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA079043
Marketing category
ANDA
Marketing start
2022-07-22
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
180 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0007FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL 24 HOUR (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [RITE AID CORPORATION]4Legacy NDC20240131_32120788-be44-8ff8-ca2c-7259375c5e45.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0007-2118220007022 BLISTER PACK in 1 CARTON (11822-0007-2) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2022-07-220000-00-00NoNoCurrent
11822-0007-3118220007033 BLISTER PACK in 1 CARTON (11822-0007-3) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2022-07-220000-00-00NoNoCurrent