NDC 28595-805

HISTEX

Triprolidine Hydrochloride

HISTEX is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Allegis Pharmaceuticals, Llc. The primary component is Triprolidine Hydrochloride.

Product ID28595-805_145e5e82-705c-499d-8bf6-863858e2d8f0
NDC28595-805
Product TypeHuman Otc Drug
Proprietary NameHISTEX
Generic NameTriprolidine Hydrochloride
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2017-07-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAllegis Pharmaceuticals, LLC
Substance NameTRIPROLIDINE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 28595-805-60

60 TABLET, CHEWABLE in 1 BOTTLE (28595-805-60)
Marketing Start Date2017-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 28595-805-60 [28595080560]

HISTEX TABLET, CHEWABLE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-07-24
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
TRIPROLIDINE HYDROCHLORIDE1.25 mg/1

OpenFDA Data

SPL SET ID:688f9e6a-ae7d-44d0-87bf-75a447acf999
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1939354
  • 1939361
  • UPC Code
  • 0328595805603
  • NDC Crossover Matching brand name "HISTEX" or generic name "Triprolidine Hydrochloride"

    NDCBrand NameGeneric Name
    28595-802HISTEXTRIPROLIDINE HYDROCHLORIDE
    28595-805HISTEXTRIPROLIDINE HYDROCHLORIDE
    69784-803AllerdineTRIPROLIDINE HYDROCHLORIDE
    58809-740Childrens PediaClear AllergyTRIPROLIDINE HYDROCHLORIDE
    58809-651Childrens PediaClear PDTRIPROLIDINE HYDROCHLORIDE
    70868-701Dr Manzanilla InfantTRIPROLIDINE HYDROCHLORIDE
    70868-702Dr Manzanilla PediatricTRIPROLIDINE HYDROCHLORIDE
    28595-801HISTEX PD DropsTRIPROLIDINE HYDROCHLORIDE
    28595-808HISTEX PDX DropsTRIPROLIDINE HYDROCHLORIDE
    58657-535M-Hist PDTRIPROLIDINE HYDROCHLORIDE
    70868-730Miclara LQTRIPROLIDINE HYDROCHLORIDE
    0536-1257TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDE
    0536-1258TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDE
    59556-896TRIPROLIDINE HYDROCHLORIDEtriprolidine hydrochloride
    69367-185Triprolidine HydrochlorideTRIPROLIDINE HYDROCHLORIDE
    69367-186Triprolidine HydrochlorideTRIPROLIDINE HYDROCHLORIDE
    69367-253TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDE
    69784-102Triprolidine HydrochlorideTRIPROLIDINE HYDROCHLORIDE
    58809-485VanaClearTriprolidine Hydrochloride
    58809-501VANAHIST PDTRIPROLIDINE HYDROCHLORIDE

    Trademark Results [HISTEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HISTEX
    HISTEX
    86144371 4568387 Live/Registered
    Velocity Consulting Specialist
    2013-12-16
    HISTEX
    HISTEX
    75359246 not registered Dead/Abandoned
    CTex Pharmaceuticals, Inc.
    1997-09-18

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.