NDC 50580-342

SUDAFED 12 HOUR

Pseudoephedrine Hydrochloride

SUDAFED 12 HOUR is a Oral Tablet, Film Coated, Extended Release 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 ID50580-342_056dd304-133c-4e19-ae29-05de311b0077
NDC50580-342
Product TypeHuman Otc Drug
Proprietary NameSUDAFED 12 HOUR
Generic NamePseudoephedrine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA075153
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength120 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-342-01

1 BLISTER PACK in 1 CARTON (50580-342-01) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2017-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-342-02 [50580034202]

SUDAFED 12 HOUR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075153
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-09-01

NDC 50580-342-01 [50580034201]

SUDAFED 12 HOUR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075153
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-09-01

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

OpenFDA Data

SPL SET ID:51bb5e49-6ae1-4321-865d-d7cff1e0097c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049668
  • 1049154

    • NDC Crossover Matching brand name "SUDAFED 12 HOUR" or generic name "Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    50090-1106Sudafed 12 HourSudafed 12 Hour
    50090-3287SUDAFED 12 HOURSUDAFED 12 HOUR
    50580-342SUDAFED 12 HOURSUDAFED 12 HOUR
    50580-670Sudafed 12 HourSudafed 12 Hour
    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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