NDC 0536-1242

Fexofenadine HCl and Pseudoephedrine HCI

Fexofenadine Hcl And Pseudoephedrine Hci

Fexofenadine HCl and Pseudoephedrine HCI is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride.

Product ID0536-1242_35d5bdde-cb43-ed3c-3a7c-075b259523dd
NDC0536-1242
Product TypeHuman Otc Drug
Proprietary NameFexofenadine HCl and Pseudoephedrine HCI
Generic NameFexofenadine Hcl And Pseudoephedrine Hci
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA076667
Labeler NameRUGBY LABORATORIES
Substance NameFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0536-1242-07

6 BLISTER PACK in 1 CARTON (0536-1242-07) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2019-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1242-34 [00536124234]

Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076667
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-08-26

NDC 0536-1242-07 [00536124207]

Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076667
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-08-26

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:556cf7e5-d177-85c1-9c21-f34e9a8271eb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997406
  • NDC Crossover Matching brand name "Fexofenadine HCl and Pseudoephedrine HCI" or generic name "Fexofenadine Hcl And Pseudoephedrine Hci"

    NDCBrand NameGeneric Name
    0363-0448Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    0363-1606Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    0536-1242Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    11673-032Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    21130-557Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    30142-447Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    30142-611Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    37808-022Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    43598-823Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    49035-273Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    55111-447Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    55111-557Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    59779-508Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    69842-249Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCI
    70000-051812HR Allergy and Congestion ReliefFexofenadine HCl and Pseudoephedrine HCI
    11822-7388Allergy and CongestionFexofenadine HCl and Pseudoephedrine HCI
    62011-0455Allergy and CongestionFexofenadine HCl and Pseudoephedrine HCI

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