NDC 0904-5803

SudoGest

Pseudoephedrine Hydrochloride

SudoGest is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Pseudoephedrine Hydrochloride.

Product ID0904-5803_728a3e68-532a-410b-b67c-6d53e54003f3
NDC0904-5803
Product TypeHuman Otc Drug
Proprietary NameSudoGest
Generic NamePseudoephedrine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2006-04-28
Marketing End Date2020-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA077442
Labeler NameMajor Pharmaceuticals
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength120 mg/1
NDC Exclude FlagN

Packaging

NDC 0904-5803-15

10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0904-5803-15)
Marketing Start Date2006-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-5803-15 [00904580315]

SudoGest TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077442
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2006-04-28
Marketing End Date2020-08-31

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

OpenFDA Data

SPL SET ID:4ea51d10-4fb8-4fc3-b6b0-1ffef3085b97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049156
  • 1049154
  • 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

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