12HR Allergy and Congestion Relief

Product NDC
70000-0518
11-digit product format
700000518
Labeler code
70000
Product ID
70000-0518_3e0fb8ba-3cc8-ca0a-94da-62af8d6689aa
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA076667
Marketing category
ANDA
Marketing start
2019-10-08
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0518-1EA - Each70000-051861305e2a-78c4-4bb6-ab44-0d68692a073d12020-06-05
70000-0518-2EA - Each70000-051852f41417-33c8-4713-a819-de1e0661fc2912022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-051812HR ALLERGY AND CONGESTION RELIEF (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI) TABLET, EXTENDED RELEASE [CARDINAL HEALTH]5Legacy NDC20241031_85e8f580-0b05-81cf-5e0f-f5a176e82766.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0518-1700000518014 BLISTER PACK in 1 CARTON (70000-0518-1) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2019-10-080000-00-00NoNoCurrent
70000-0518-2700000518026 BLISTER PACK in 1 CARTON (70000-0518-2) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2021-08-130000-00-00NoNoCurrent