Fexofenadine HCl and Pseudoephedrine HCI

Product NDC
0536-1242
11-digit product format
005361242
Labeler code
0536
Product ID
0536-1242_35d5bdde-cb43-ed3c-3a7c-075b259523dd
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
ANDA076667
Marketing category
ANDA
Marketing start
2019-08-26
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1242-07EA - Each0536-12422645b64e-e5fd-4513-90ae-d212a1c8924412019-12-10
0536-1242-34EA - Each0536-12423fa7225a-26cf-4d67-bce7-0b9f9dca1b5612019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1242FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [RUGBY LABORATORIES]4Legacy NDC20241031_556cf7e5-d177-85c1-9c21-f34e9a8271eb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1242-07005361242076 BLISTER PACK in 1 CARTON (0536-1242-07) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2019-08-260000-00-00NoNoCurrent
0536-1242-34005361242344 BLISTER PACK in 1 CARTON (0536-1242-34) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2019-08-260000-00-00NoNoCurrent