NDC 63187-541

SudoGest

Pseudoephedrine Hydrochloride

SudoGest is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Pseudoephedrine Hydrochloride.

Product ID63187-541_2b08189d-4bcb-475e-aa28-a8f693cffd76
NDC63187-541
Product TypeHuman Otc Drug
Proprietary NameSudoGest
Generic NamePseudoephedrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1994-10-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameProficient Rx LP
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63187-541-15

15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-541-15)
Marketing Start Date2018-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-541-15 [63187054115]

SudoGest TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-01

NDC 63187-541-90 [63187054190]

SudoGest TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-01

NDC 63187-541-30 [63187054130]

SudoGest TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-01

NDC 63187-541-60 [63187054160]

SudoGest TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-01

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:52ab64d7-b4c8-45d1-8e45-271f4dda1420
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049169
  • 1049167
  • NDC Crossover Matching brand name "SudoGest" or generic name "Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    0904-5053SudoGestPseudoephedrine HCl
    0904-5125SudoGestPseudoephedrine Hydrochloride
    0904-5351SudoGestChlorpheniramine maleate, pseudoephedrine HCl
    0904-5803SudoGestPseudoephedrine Hydrochloride
    0904-6338SudoGestPSEUDOEPHEDRINE HCL
    21695-806SudoGestPseudoephedrine Hydrochloride
    21695-898SudoGestPseudoephedrine Hydrochloride
    70518-0119SudoGestSudoGest
    70518-0121SudoGestSudoGest
    71205-133SudoGestSudoGest
    33261-651SudoGestSudoGest
    50090-0155SudoGestSudoGest
    50090-0157SudoGestSudoGest
    50090-1961SudoGestSudoGest
    50090-1955SudoGestSudoGest
    50436-0333SudoGestSudoGest
    52959-260SudoGestSudoGest
    63187-541SudoGestSudoGest
    63629-1491SudoGestSudoGest
    66336-096SudoGestSudoGest
    0113-205412 hour decongestantPseudoephedrine Hydrochloride
    30142-05412 hour decongestantPseudoephedrine Hydrochloride
    24385-054good neighbor pharmacy nasal decongestantPseudoephedrine Hydrochloride
    0113-0054Good Sense SuphedrinePseudoephedrine Hydrochloride
    0363-3301Nasal Decongestant DPseudoephedrine Hydrochloride
    0363-0204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0904-6727Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0904-6728Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0904-6907Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    21130-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0536-1850RugbyPseudoephedrine Hydrochloride
    0113-0401Zephrex Dpseudoephedrine hydrochloride

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