NDC 50580-250

SUDAFED Sinus Congestion

Pseudoephedrine Hydrochloride

SUDAFED Sinus Congestion is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Pseudoephedrine Hydrochloride.

Product ID50580-250_25fd8f45-077a-450d-8c16-b9e9dee6d8b0
NDC50580-250
Product TypeHuman Otc Drug
Proprietary NameSUDAFED Sinus Congestion
Generic NamePseudoephedrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-06-17
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-250-01

2 BLISTER PACK in 1 CARTON (50580-250-01) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-250-02 [50580025002]

SUDAFED Sinus Congestion TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-17

NDC 50580-250-03 [50580025003]

SUDAFED Sinus Congestion TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-17

NDC 50580-250-01 [50580025001]

SUDAFED Sinus Congestion TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-17

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:b73ddc2c-ad28-4dba-8304-3407b6193373
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049160
  • 1049529
    • UPC Code
  • 0300810865487

    • NDC Crossover Matching brand name "SUDAFED Sinus Congestion" or generic name "Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-250SUDAFED Sinus CongestionSUDAFED Sinus Congestion
    0113-205412 hour decongestantPseudoephedrine Hydrochloride
    30142-05412 hour decongestantPseudoephedrine Hydrochloride
    41250-05412 hour decongestantPseudoephedrine Hydrochloride
    41163-054Equaline 12 Hour DecongestantPseudoephedrine Hydrochloride
    24385-054good neighbor pharmacy nasal decongestantPseudoephedrine Hydrochloride
    0113-0054Good Sense SuphedrinePseudoephedrine Hydrochloride
    37205-446Leader 12 Hour Nasal DecongestantPseudoephedrine 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
    30142-967Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDE
    37012-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    37808-007Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    37808-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0536-1850RugbyPseudoephedrine Hydrochloride
    30142-613sinusPseudoephedrine hydrochloride
    0904-5125SudoGestPseudoephedrine Hydrochloride
    0904-5803SudoGestPseudoephedrine Hydrochloride
    21695-806SudoGestPseudoephedrine Hydrochloride
    21695-898SudoGestPseudoephedrine Hydrochloride
    33261-651SudoGestPseudoephedrine Hydrochloride
    36800-054topcare 12 hour decongestantPseudoephedrine Hydrochloride
    0113-0401Zephrex Dpseudoephedrine hydrochloride
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