NDC 28595-250

HISTEX AC

Codeine Phosphate, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride

HISTEX AC is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Allegis Pharmaceuticals, Llc. The primary component is Codeine Phosphate; Phenylephrine Hydrochloride; Triprolidine Hydrochloride.

Product ID28595-250_07d6bef9-8aa3-43f5-b903-63a06ff7136f
NDC28595-250
Product TypeHuman Otc Drug
Proprietary NameHISTEX AC
Generic NameCodeine Phosphate, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2015-08-12
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAllegis Pharmaceuticals, LLC
Substance NameCODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL; mg/5mL
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 28595-250-16

473 mL in 1 BOTTLE (28595-250-16)
Marketing Start Date2015-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 28595-250-16 [28595025016]

HISTEX AC SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-08-12

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE10 mg/5mL

OpenFDA Data

SPL SET ID:d5919b31-8191-4827-90d4-7782dcf539a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1661319
  • 1661325

    • Medicade Reported Pricing

    28595025016 HISTEX-AC SYRUP

    Pricing Unit: ML | Drug Type:

    Trademark Results [HISTEX AC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HISTEX AC
    HISTEX AC
    86729680 not registered Dead/Abandoned
    Velocity Consulting Specialist
    2015-08-19
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.