NDC 50580-545

SUDAFED

Pseudoephedrine Hydrochloride

SUDAFED is a Oral Tablet, 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 ID50580-545_0243c7ca-77fa-4189-bce2-ada15361b6cb
NDC50580-545
Product TypeHuman Otc Drug
Proprietary NameSUDAFED
Generic NamePseudoephedrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2011-10-01
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 50580-545-24

3 BLISTER PACK in 1 CARTON (50580-545-24) > 8 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2015-07-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-545-96 [50580054596]

SUDAFED TABLET, COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-10-01
Marketing End Date2015-05-29

NDC 50580-545-24 [50580054524]

SUDAFED TABLET, COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-07-13

NDC 50580-545-48 [50580054548]

SUDAFED TABLET, COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-07-13

NDC 50580-545-50 [50580054550]

SUDAFED TABLET, COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-10-01
Marketing End Date2015-05-29

NDC 50580-545-72 [50580054572]

SUDAFED TABLET, COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-29

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:d280abe9-6bdf-4e1e-a0cf-95fd0451c999
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049160
  • 1049529

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

    NDCBrand NameGeneric Name
    50580-545SUDAFEDSUDAFED
    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

    Trademark Results [SUDAFED]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SUDAFED
    SUDAFED
    98369359 not registered Live/Pending
    KENVUE INC.
    2024-01-22
    SUDAFED
    SUDAFED
    97338518 not registered Live/Pending
    JOHNSON & JOHNSON
    2022-04-05
    SUDAFED
    SUDAFED
    78766059 3624735 Dead/Cancelled
    JOHNSON & JOHNSON
    2005-12-03
    SUDAFED
    SUDAFED
    78158808 not registered Dead/Abandoned
    Warner-Lambert Company
    2002-08-28
    SUDAFED
    SUDAFED
    77939980 4222270 Live/Registered
    JOHNSON & JOHNSON
    2010-02-19
    SUDAFED
    SUDAFED
    77939929 4125977 Live/Registered
    JOHNSON & JOHNSON
    2010-02-19
    SUDAFED
    SUDAFED
    76462993 2741719 Live/Registered
    JOHNSON & JOHNSON
    2002-10-28
    SUDAFED
    SUDAFED
    73400915 1266826 Live/Registered
    Burroughs Wellcome Co.
    1982-10-27
    SUDAFED
    SUDAFED
    71623397 0565723 Live/Registered
    BURROUGHS WELLCOME & CO. (U.S.A.) INC.
    1952-01-10
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