Fexofenadine HCl and Pseudoephedrine HCl

Product NDC
70000-0607
11-digit product format
700000607
Labeler code
70000
Product ID
70000-0607_5ce1bb61-ffe3-38fe-18ef-99d50c0c058f
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA079043
Marketing category
ANDA
Marketing start
2022-05-16
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
70000-0607FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL 24 HOUR (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [CARDINAL HEALTH]3Legacy NDC20240131_3d79bfa5-ae6a-988f-6346-705a0ecaa82a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0607-1700000607012 BLISTER PACK in 1 CARTON (70000-0607-1) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2022-05-160000-00-00NoNoCurrent