Allergy and Congestion

Product NDC
62011-0455
11-digit product format
620110455
Labeler code
62011
Product ID
62011-0455_a651e527-95f4-2565-3ea0-dd5173944cd8
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Strategic Sourcing Services, LLC
Application
ANDA076667
Marketing category
ANDA
Marketing start
2020-07-27
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60 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
62011-0455ALLERGY AND CONGESTION (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI) TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES, LLC]5Legacy NDC20241031_ec4f6fca-8b96-ef45-f072-c8683572853a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0455-1620110455014 BLISTER PACK in 1 CARTON (62011-0455-1) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2020-07-270000-00-00NoNoCurrent